Engineering Jobs in Aliso Viejo, CA

Job Title: Product Manager

Location: Irvine, CA

Reports to: Director, Product Manager

FLSA Status: Exempt

About Our Organization: RIS Rx (pronounced "RISE Rx") is on a mission to make every dollar allocated for affordability count, delivering true impact for the patients and pharma manufacturers we serve. We’ve built the industry’s first real-time, pharmacist-led GTN Revenue Performance platform, restoring trust, visibility, and integrity to patient affordability.

What sets us apart? Our team combines deep pharmacy roots with cutting-edge technology, tackling patient access barriers in smarter, more human ways. Our people-first culture means you’ll find career growth, great benefits, and a supportive environment waiting for you, because we believe when people thrive, everyone wins.

Join us and help shape a better, brighter future for patient access.

Job Summary

We are seeking an experienced Product Manager to lead the vision, strategy, and execution of innovative software solutions that address key challenges in healthcare technology. This role will focus on driving patient affordability, optimizing gross-to-net (GTN) processes, and mitigating risk for pharmaceutical manufacturers. The Product Manager will serve as the bridge between business, technical, and clinical stakeholders, ensuring products deliver measurable value and align with company objectives. The ideal candidate is a strategic thinker with strong analytical skills, a proven ability to manage the full product lifecycle, and a passion for improving outcomes in the pharmaceutical and healthcare space.

Responsibilities

• Define and own the product vision, strategy, and roadmap for software solutions that address healthcare technology challenges, including patient affordability, gross-to-net (GTN) optimization, and risk mitigation for pharmaceutical manufacturers
• Translate complex business requirements into clear product specifications, user stories, and acceptance criteria for engineering teams
• Collaborate closely with engineering, pharmacists, operations, data analysts, and business stakeholders to ensure product initiatives align with company objectives and customer needs
• Drive the full product lifecycle from ideation to launch, including requirements gathering, prioritization, development, testing, release, and post-launch evaluation
• Lead backlog grooming, sprint planning, and cross-functional standups, ensuring timely delivery of high-quality product releases
• Analyze solution usage data, industry trends, and feedback to inform product decisions and identify new opportunities for innovation and differentiation
• Partner with marketing, sales, and customer implementation teams to support go-to-market activities, product positioning, and customer adoption
• Establish and track key performance indicators (KPIs) to measure product success and drive continuous improvement
• Maintain deep awareness of pharmaceutical trends, regulatory requirements, and competitive landscape to guide long-term product strategy
• Serve as the voice of the customer and ensure that product decisions balance user needs, business objectives, and technical feasibility

Skills

• 5+ years of experience in product management, preferably in healthcare technology, SaaS, or pharmaceutical services
• Experience using product management software (e.g., Jira, Aha!) to manage roadmaps, backlogs, and requirements
• Proven track record of managing software products from concept through launch and iteration
• Strong understanding of Agile/Scrum methodologies and experience working with engineering teams in iterative development environments
• Familiarity with healthcare or pharmaceutical industry processes strongly preferred
• Experience working with cloud-based platforms (AWS or similar), data analytics tools, and software development concepts
• Strong analytical skills with ability to interpret usage data, market research, and financial metrics to drive product decisions
• Excellent leadership and collaboration skills, with experience influencing stakeholders across technical and non-technical teams
• Exceptional communication skills with the ability to explain product decisions and technical trade-offs clearly to executives, customers, and development teams
• Ability to balance strategic vision with day-to-day execution and delivery in a fast-paced environment
• Strong problem-solving skills and the ability to anticipate and resolve complex product challenges

Education

• This position requires a Bachelor’s degree; MBA or advanced degree preferred

What we offer:

• Free gym membership
• Modern office
• Annual merit-based salary increases
• 401(k) with annual company match
• Medical - RIS Rx covers 100% of the employee’s base HMO medical plan
• Voluntary Dental, Vision & Life Insurance
• Flexible Savings Account (FSA)
• Paid Holidays
• Time off that grows with you:
• 3 weeks PTO 0-2 years
• 4 weeks PTO after 3+ years
• 5 weeks PTO after 5+ years
• Recognition programs that celebrate impact and results
• Mentorship and coaching opportunities
• Clear growth paths and career development support
• Fully stocked snack kitchen
• Company-paid lunches

Mechanical Engineer – Aerospace Thermal Management Systems (Integration & Packaging)

Location: Onsite – Irvine CA

Industry: Aerospace & Defense

Duration: 6 months and extendable

Role Overview

We are seeking two highly skilled Mechanical Engineers with experience in the Aerospace & Defense sector to support the development and integration of advanced thermal management subsystems used across military and commercial platforms globally.

This role focuses on mechanical subsystem development from a packaging and integration perspective, including enclosure design and integration of electronic and fluid control components such as pumps, compressors, fans, and valves. The ideal candidate has hands-on experience developing aerospace-grade subsystems within defined volume and interface constraints, ensuring high reliability, environmental robustness, and compliance with industry standards.

These roles will support programs progressing from Preliminary Design Review (PDR) toward Critical Design Review (CDR) and will involve reuse and adaptation of existing product architectures.

Key Responsibilities

• Design and develop mechanical enclosures for aerospace electronic and control subsystems such as thermal management systems and related subsystems
• Package and integrate COTS and custom components into customer-defined volume constraints by integrating components including pumps, compressors, fans, valves, and control electronics
• Develop detailed CAD models, assemblies, and manufacturing drawings (SolidWorks preferred)
• Conduct tolerance analysis, GD&T, stack-up analysis, and design for manufacturability (DFM)
• Support prototype builds, integration activities, testing, and validation
• Implement design considerations to satisfy and qualify the environmental requirements (shock, vibration, temperature, humidity, EMI/EMC interface considerations) per MIL standards.
• Collaborate with electrical, controls, thermal, structural, and systems engineering teams
• Participate in root cause analysis and design refinement
• Ensure compliance with aerospace and defense standards and documentation practices

Required Qualifications

• Bachelor’s degree in mechanical engineering or equivalent.
• 5+ years of experience in Aerospace & Defense mechanical subsystem development
• U.S. Citizen (No Dual Citizenship)
• Strong mechanical packaging and integration experience
• Experience designing enclosures housing electronics and fluid/mechanical components
• Exposure to thermal management systems (ECS, vapor cycle, or liquid cooling preferred but not mandatory)
• Working knowledge of rotating machinery components (fans, compressors, pumps)
• Proficiency in CAD tools (SolidWorks preferred; strong experience in other platforms acceptable)
• Experience with GD&T and tolerance analysis
• Familiarity with aerospace environmental standards (MIL-STD preferred)
• Experience supporting qualification and validation testing
• Strong understanding of materials selection for aerospace applications
• Ability to work in cross-functional engineering teams

Preferred Qualifications

• Experience packaging turbomachinery components within constrained aerospace envelopes
• Exposure to controls systems integration
• Knowledge of vibration isolation and shock mitigation techniques
• Experience supporting PDR/CDR processes
• Familiarity with configuration management and aerospace documentation rigor
• Exposure to FMEA, reliability analysis, and lifecycle support

Seeking an experienced Director of Service Operations to lead and elevate national service performance. This role is responsible for delivering exceptional customer support, optimizing field operations, and ensuring strong alignment between internal teams and an external dealer service network.

Key Responsibilities

• Lead, mentor, and develop the service organization, including technical support, dispatch, warranty, coordination, training, and field service teams.
• Oversee national day-to-day service operations to ensure timely, high-quality customer support and field response.
• Own warranty claim processes, root-cause analysis, and corrective action initiatives to improve product reliability and customer satisfaction.
• Direct parts, dispatch, and service coordination functions to optimize scheduling, resource allocation, and issue resolution.
• Establish and lead service training programs supporting continuous development of customer service and technical personnel.
• Drive operational excellence through KPI development, performance tracking, and implementation of standardized operating procedures.
• Partner closely with engineering, production, and sales teams to translate customer feedback into product and process improvements.
• Strengthen relationships with a nationwide dealer service network, ensuring alignment on performance expectations, training, and service standards.
• Deliver executive-level reporting on service performance, trends, risks, and improvement opportunities.
• Foster a culture of accountability, collaboration, and customer-first execution across the service organization.

Qualifications & Experience

• 5–10 years of leadership experience managing service or technical support organizations within manufacturing, automotive, industrial equipment, or related technical environments.
• Demonstrated success leading cross-functional service teams in fast-paced, customer-driven organizations.
• Strong understanding of field service workflows, warranty management, parts operations, and customer service best practices.
• Proven ability to analyze performance data, establish measurable goals, and drive operational accountability.
• Excellent leadership, communication, and stakeholder influence skills.
• High emotional intelligence with a coaching-oriented leadership style.
• Technical aptitude related to electrical, mechanical, or charging systems strongly preferred.
• Passion for building scalable service organizations and delivering exceptional customer experiences.

Product Development Manager - hardgoods

This role supports the planning, development, and release of consumer-focused products within assigned categories. The Product Manager partners with cross-functional stakeholders to translate customer needs into clear product requirements, coordinate execution across teams, and help drive successful launches and ongoing product performance.

Key Responsibilities

• Contribute to category plans by helping define product direction, timelines, and release milestones.
• Research customers, competitors, and market dynamics to uncover trends, unmet needs, and product opportunities.
• Work with internal teams (e.g., sales, marketing/brand, design/creative, operations, and engineering/development) to support product creation and launch readiness.
• Help document product requirements, user needs, and feature details; maintain organized records as products progress through development.
• Coordinate launch deliverables such as imagery, product content, sales enablement materials, and channel-ready assets in partnership with creative and digital teams.
• Support SKU setup, pricing/cost inputs, assortment updates, and other lifecycle activities from introduction through end-of-life.
• Track product results post-launch, summarize insights, and recommend improvements for future iterations and releases.
• Manage multiple workstreams at once, ensuring alignment on priorities, dependencies, and deadlines.

Qualifications

• 2–3 years of experience supporting product management, product development, or category management for consumer products
• Experience collaborating with technical or development teams to define and maintain product requirements and specifications.
• Bachelor’s degree in business, marketing, economics, or a related discipline
• Strong analytical skills with the ability to synthesize qualitative feedback and quantitative data into actionable insights.
• Clear written and verbal communication skills, including comfort presenting updates to stakeholders.
• Highly organized, detail-oriented, and proactive, with strong follow-through.
• Collaborative working style and ability to build productive partnerships across functions.

Senior Technical Writer / Lead (Engineering SME)

Hybrid

Irvine, CA

Role Summary

The Senior Technical Writer / Lead will serve as the primary lead for documentation quality, consistency, and coordination across validation reporting and planning activities. This individual will work closely with Auto OEM engineering teams to synthesize technical inputs into formal reports and plans while helping define future-state templates and documentation standards.

Key Responsibilities

• Lead preparation and standardization of validation test reports and test plans
• Convert raw test data and engineering inputs into accurate, structured, and professional technical documentation
• Collaborate with validation and engineering teams to gather input, clarify requirements, and ensure technical accuracy
• Establish consistency in document structure, language, terminology, and quality across deliverables
• Help develop and refine future-state reports and plan templates
• Create or coordinate technical diagrams, set up illustrations, and procedural content as required
• Guide supporting writers and minimizing ramp-up time for the extended team
• Work within Auto OEM systems and workflows, including Jira, Hex, and other internal platforms

Required Qualifications

• Bachelor’s degree in engineering or a related technical discipline
• Proven experience in technical writing within engineering, validation, testing, or product development environments
• Strong ability to interpret engineering discussions, data sets, and validation outputs
• Experience developing test reports, validation documentation, test plans, procedures, and technical templates
• Demonstrated ability to lead technical documentation workstreams or coordinate multi-resource delivery
• Strong communication, documentation, and stakeholder management skills
• Must be able to work in a hybrid onsite U.S. model

Preferred Qualifications

• Experience in automotive, EV, systems engineering, or validation environments
• Familiarity with engineering data, test setups, and documentation workflows in hardware or vehicle programs
• Experience producing diagrams, process visuals, or setup illustrations as part of technical documentation

Senior Product Designer – Softgoods (Golf Bags & Luggage)

Ghost Golf | Irvine, California | Full-Time | On-Site

Ghost Golf is one of the fastest-growing premium brands in golf. We design high-performance golf bags, accessories, and apparel for golfers who demand exceptional quality, thoughtful functionality, and modern design.

As our brand continues to grow, we are making a significant investment in expanding our golf bag and travel product categories, including the development of a complete luggage ecosystem designed specifically for the modern golf traveler.

We are seeking an experienced Senior Product Designer – Softgoods to help lead the design and development of these products. This role will focus heavily on golf bags, travel bags, and luggage, and requires deep experience in softgoods design, materials, construction, and factory development.

The ideal candidate has experience designing and bringing complex bag products to market and understands the entire process from concept to manufacturing.

This position is based in Irvine, California and requires full-time, in-office work. Remote or hybrid arrangements are not available.

Role Overview

The Senior Product Designer will play a critical role in shaping the future of Ghost Golf’s golf bag and travel product lines.

This role involves improving existing products while designing entirely new categories of bags and travel gear. The position requires a strong balance of creative design, technical product development, and factory collaboration.

You will work closely with internal teams and manufacturing partners to ensure products are designed, developed, and produced at the highest level of quality and performance.

Essential Job Duties and Responsibilities

Design and develop premium golf bags, travel bags, and luggage systems that align with the Ghost Golf brand and product standards.

Responsibilities include:

• Designing new golf bags and improving existing bag products
• Leading the design and development of a complete luggage system for golf travel, including carry-on luggage, check-in luggage, duffels, backpacks, garment bags, and travel accessories
• Translating product concepts into technical drawings and production-ready tech packs
• Selecting and sourcing materials including fabrics, trims, hardware, zippers, and structural components
• Working directly with factories to review samples, refine construction methods, and solve development challenges
• Managing the sampling and prototype process through development and pre-production
• Ensuring designs meet requirements for functionality, durability, quality, and manufacturability
• Collaborating with product, sourcing, and leadership teams throughout the development process
• Researching new materials, technologies, and manufacturing techniques relevant to softgoods design
• Managing multiple product developments while maintaining development timelines

Minimum Requirements and Qualifications

A suitable background would include the following experience and qualifications:

• Minimum 7+ years of experience designing softgoods products
• Experience designing golf bags, travel bags, luggage, or similar technical bag products
• Degree from a recognized design school (Industrial Design, Product Design, Fashion Design, or related field)
• Proven ability to create detailed tech packs for manufacturing
• Strong understanding of softgoods construction, materials, and bag engineering
• Experience working directly with overseas factories and manufacturing partners
• Strong knowledge of fabrics, trims, hardware, and bag construction techniques
• Proficiency in Adobe Illustrator and standard product development tools
• Ability to manage multiple product developments simultaneously
• Strong communication and collaboration skills

Preferred Experience

• Direct experience designing golf bags
• Experience developing luggage systems or travel collections
• Experience working with premium materials and high-end products
• Experience working with Asian manufacturing partners

Candidates without golf industry experience may still be considered if they bring exceptional experience designing luggage or technical softgoods products.

To Be Successful in This Role

The ideal candidate demonstrates:

• Deep understanding of bag design and softgoods construction
• Strong attention to detail and product execution
• Ability to balance design vision, functionality, and manufacturability
• Comfort working directly with factories to refine designs
• Passion for building exceptional products and pushing design forward

Location

This role is based in Irvine, California.

This is a full-time, in-office position.

Remote or hybrid work arrangements are not available.

How to Apply

To be considered for this role, candidates must email their application materials directly.

Please send the following to:

Include:

• Resume

• Portfolio link or PDF showcasing softgoods design work

• Examples of bags, luggage, travel gear, or similar products you have designed

Email Subject Line: Senior Softgoods Designer Application – [Your Name]

Applications submitted through LinkedIn or other job platforms without emailing the required materials will not be reviewed.

Job Title: R&D Test Engineer

Location: Irvine, CA

Employment Type: Full-Time

Position Overview

We are seeking R&D Test Engineers to support the development and verification of innovative drug delivery and medical device products. The selected candidates will contribute to verification and validation activities, test method development, and product testing to ensure compliance with regulatory and internal quality standards.

This role involves working closely with cross-functional teams including R&D, Quality, Manufacturing, and Regulatory Affairs to support product development, verification strategies, and root cause investigations.

Key Responsibilities

• Assist in the development and testing of innovative drug delivery products.
• Define and execute verification strategies, including development of verification plans, protocols, records, and reports.
• Develop scientifically justified sample size strategies in compliance with internal and regulatory requirements.
• Design and execute engineering and verification test procedures.
• Prepare test protocols and documentation, maintain accurate laboratory notebooks, and present results to cross-functional teams.
• Analyze test data and provide technical insights and recommendations.
• Lead or support root cause investigations and implement issue resolutions.
• Define, develop, and validate test methods for product verification.
• Recommend design, process, or project improvements to enhance product performance and development efficiency.
• Ensure compliance with company policies, regulatory standards, and safety procedures.
• Review and evaluate design changes for technical and regulatory compliance.
• Conduct tests to determine physical and mechanical characteristics of materials for quality control, process control, and product development.
• Perform technical tasks according to quality and functional standards.

Required Qualifications

R&D Test Engineer

• Experience in R&D testing, product development, or verification within engineering environments.
• Strong experience in verification planning, protocol development, and testing execution.
• Demonstrated ability to lead root cause investigations and technical problem-solving.
• Experience working in regulated industries (medical devices preferred).
• Strong technical documentation and cross-functional communication skills.
• experience in engineering testing, product development, or laboratory environments.
• Basic knowledge of engineering test methods and verification processes.
• Ability to perform testing, data analysis, and documentation under supervision.
• Strong analytical and problem-solving skills.

Preferred Skills & Tools

Experience with the following tools and technologies is preferred:

Testing & Lab Equipment

• Zwick or Instron testing systems
• Flow measurement equipment
• Viscometers
• Climate chambers
• 3D printing technologies

Engineering & Data Tools

• SolidWorks
• Minitab
• Electronic Lab Notebook (ELN)

Project & Requirements Management

• Microsoft Project
• Laboratory Information Management Systems (LIMS) such as LinkUS
• Requirements and Risk Management tools such as DOORS or Cockpit

Mechanical Assembler
Tustin, CA
6 Month Contract to Hire
$20-$21 an hour

Summary: 

Immediate hire at thriving company. Will be responsible for filling out the verification sheet for each job assigned. Reading and understanding assembly drawings. Read and understand assembly, test and packaging procedures. Complete necessary paperwork accurately for each Job order following GDP (Good Documentation Practices). Follow 5s processes. Package and label all products including batteries from cleanroom. Set up, Client out parts and maintain a clean working environment at all times . Performs a range of routine mechanical assembly of small parts or components in accordance with company instructions and procedures . Performs mechanical assemblies, subassemblies and potting. Visually inspect assemblies and subassemblies in progress to ensure compliance with assembly drawings and assembly procedures. Test air motor, medical devices following test established procedures. Reports on any unusual problems that occur during testing, packaging or assembling components. Notify assembly supervisor or manager of discrepancies. Identify non -conformance and initiate require documentation. Documentation may include (Non - conforming material report). Request parts from stockroom when needed. Sign and approve first articles.

Requirements:

• Understand Clock ON and Clock OFF Jobs.
• Strong attention to detail in every assembly, or task assigned.
• Able to read and understand work orders, interpret drawings and assembly procedures.
• Experience using hand tools and equipment to aid assembly.
• Ability to operate drill press, a variety air equipment, and electrical tools.

Welcome to ConsultNet, a premier national provider of technology talent and solutions. Our expertise spans across project services, contract-to-hire, direct search, and managed services onshore, nearshore, and hybrid. For over 25 years, we have connected thousands of consultants with meaningful roles through a personal, communication-driven approach, partnering with a diverse client base to build high-performing teams and create lasting impact. Our comprehensive service offerings cover a wide range of technology and engineering positions across key markets nationwide. Learn more at .

We champion equality and inclusivity, proudly supporting an Equal Opportunity Employer policy. We welcome applicants regardless of Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other status protected by law.

Full-Time, Direct-Hire, Onsite

Monday-Friday 9am-5:30pm

$85,000–$100,000

About The Job:

Quality Assurance & Regulatory Specialist ensures that products, processes, and documentation meet required quality standards and comply with all relevant regulatory frameworks. This role combines regulatory strategy/submissions with quality system implementation, audits, and continuous improvement to support product approval and patient safety.

Essential Duties and Responsibilities:

• Develop, implement, and maintain Quality Management Systems (QMS).

• Conduct or coordinate internal audits, supplier audits to ensure compliance with regulatory standards (e.g., CLIA, CAP)

• Oversee document control, change control, CAPA (Corrective and Preventive Actions), nonconformance management, complaint handling, and Medical Device Reporting (MDR)/Vigilance.

• Coordinate proficiency testing programs and analyze results to identify areas for improvement.

• Maintain quality documentation, SOPs, and testing procedures.

• Prepare and present quality metrics and reports for management review.

• Be familiar with laboratory protocols and procedures for specimen processing, operating equipment and instruments, maintenance of designated laboratory environment and instruments, and data analysis.

• Review and approve product labeling, packaging, promotional materials, and technical documentation for regulatory compliance.

Education and Experience:

• A minimum of 2 to 3 years of laboratory experience.

• Strong knowledge of key regulations and standards: CAP/CLIA, FDA QSR (21 CFR Part 820/211), ISO 13485/9001, MolDx, etc.

• Understanding of regulatory frameworks relevant to the industry.

• Experience with audits, compliance systems, and regulatory submissions.

• Bachelor's degree (required) in life sciences, biology, chemistry, engineering, pharmacy, or related field; advanced degree (Master's/PhD) preferred.

Preferred Experience:

• Professional certification is a plus (e.g., Regulatory Affairs Certification – RAC, ASQ Certified Quality Auditor – CQA).

• A Valid and active CLS (Generalist) or CGMBS license

WHY TENANT

At Tenant, Inc., we’re modernizing the self-storage industry through intuitive technology and customer-first solutions. You’ll work alongside thoughtful, driven teammates who value ownership, collaboration, and growth. This role offers hands-on exposure to customer success in a fast-growing SaaS environment and the opportunity to build a strong foundation for a long-term career in Customer Success.

JOB SUMMARY

The Customer Success Manager plays a key role in supporting customer adoption, satisfaction, and retention. This position partners closely with senior Customer Success, Sales, Product, and Support teams to ensure customers receive timely guidance, proactive support, and consistent value from the Tenant platform.

This role is ideal for someone who is customer-centric, organized, eager to learn, and excited to grow within a SaaS customer success organization. You will support a mix of small to mid-market and select high-touch customers while developing the skills needed to manage more complex accounts over time.

KEY RESPONSIBILITIES

Customer Ownership & Retention Support

• Manage revenue retention, engagement plans and flag at-risk in assigned customer base.
• Support a portfolio of customers by serving as a day-to-day success contact.
• Monitor customer engagement, usage, and health indicators to identify potential risks or opportunities.
• Participate in customer check-ins, QBR preparation, and follow-ups under the guidance of senior team members.
• Support renewal and expansion efforts by reinforcing product value and customer outcomes.

Customer Success Execution

• Assist with onboarding activities to help customers successfully launch and adopt the Tenant platform.
• Guide customers through product features, workflows, and best practices.
• Help maintain and update customer success playbooks, templates, and enablement materials.
• Develop deep familiarity with Tenant’s products and act as a trusted product resource for customers.

Cross-Functional Collaboration

• Partner with Sales, Support, Product, and Engineering teams to address customer needs and feedback.
• Escalate customer issues appropriately and help track resolutions.
• Assist with customer communications related to product updates or service notifications when needed.
• Maintain accurate customer records, tasks, and workflows in and other tools.

Operational Excellence & Learning

• Track customer health, adoption metrics, and engagement trends.
• Learn how to interpret customer data and translate insights into action.
• Support continuous improvement of Customer Success processes and documentation.
• Assist with support overflow or customer inquiries during peak periods.

TEAM & CULTURE

• Build strong working relationships across a collaborative, mostly remote team.
• Demonstrate a customer-first mindset, accountability, and eagerness to learn.
• Participate in team meetings, training sessions, and professional development opportunities.
• Contribute positively to a culture of growth, feedback, and shared success.

QUALIFICATIONS & EXPERIENCE

• 1–3 years of experience in a customer-facing role (Customer Success, Support, Account Management, Sales, or similar), preferably in a SaaS environment.
• Strong interest in Customer Success, customer experience, and technology.
• Excellent communication skills—written, verbal, and interpersonal.
• Highly organized with the ability to manage multiple tasks and priorities.
• Comfortable working with data and learning how to use metrics to guide decisions.
• Experience with tools like Zendesk, , CRM systems, or similar platforms is a plus.
• Curious, proactive, and motivated to grow into a more senior Customer Success role over time.

Tenant, Inc. is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, gender identity or expression, sexual orientation, national origin, age, disability, veteran status, or any other protected characteristic under applicable law. #CSMJobs, #StartupCareers, #Mondaydotcom, #Zendesk#NowHiring #CustomerSuccess #CustomerSuccessManager #SaaSJobs #CustomerExperience #CustomerRetention

#TechCareers #B2BSoftware #PropTech #SelfStorage #GrowthCareer #EarlyCareerJobs

#RemoteJobs #CustomerFirst

American Equipment Holdings is an organization of leading overhead crane and hoist fabricators, distributors and field service providers, including American Equipment, Allied Crane, Eastern Crane & Hoist, Facilities Engineering, Kistler Crane & Hoist, Pacific Crane & Hoist, Patriot Crane & Hoist, Shannahan Crane & Hoist, and Washington Crane & Hoist. The consolidated entity is one of the largest independently owned overhead crane and hoist solutions providers in the country, serving over 4,000 customers nationwide.

Together, American Equipment Holdings companies provide comprehensive solutions for everything related to customers’ overhead crane and hoist needs, including OSHA mandated inspections, preventative maintenance and repair field services, parts, engineering, ISO certified fabrication, new and replacement equipment, automated systems, system modernizations and training.

We are looking for a Field Maintenance Install Technician (Experienced Ironworker) in our Anaheim location.

Essential Duties and Responsibilities:

• Work as part of team to install equipment. With a focus on safety and customer service.
• Accurately and neatly document work performed using a combination of electronic forms, software applications, and traditional handwritten reports where required.
• Maintain a clean and safe work environment.
• Travel may be required to install sites.

Required Skills/Abilities

• Iron work/steel erection experience.
• Aptitude for either electrical or mechanical environments as well as familiarity with mechanical and electrical equipment
• Comfort with working at heights
• Welding experience- Wire Feed (MIG), Stick (SMAW)
• Hands-on electro-mechanical maintenance or equivalent military experience a plus
• Competence in equipment operation. Reach forklifts, scissor lifts.
• Ability to read blueprints and schematics
• Ability to work well in a team environment.
• Strong communication skills
• Proven commitment to safety
• Passion for doing things right the first time.
• Industry certifications including equipment operator, Welding, Rigging will be a plus.
• Willingness to work overtime is required
• Possession of a valid driver’s license with good driving record
• Must pass drug-screen and background check

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

American Equipment Holdings represents the industry’s leading manufacturers such as Detroit Hoist, Columbus McKinnon, ACCO, R&M, Demag, Gorbel, Spanco, IMS, Harrington, Conductix, Magnetek & PE, among others and customers rely on its design, engineering, fabrication and installation capabilities to meet their unique application needs. American Equipment Holdings serves local, regional and national customers across a variety of end markets, including light & heavy industrial, automotive, mining, public utilities, military, aerospace & defense and energy, among others. For more information, visit of right to lawfully work in the United States required.

We are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

Compensation details: 24-32 Hourly Wage

PI8480876da8

We are seeking a Director, Strategic Trade Compliance to join our team. In this role you will be the senior authority responsible for overseeing the company’s global import, export, and sanctions compliance programs. This role defines and executes enterprise trade compliance strategy, ensures adherence to U.S. and international trade regulations, and partners with executive leadership to mitigate regulatory risk while enabling efficient global commerce.

The Director leads a global or multi-regional team of trade professionals, governs compliance frameworks and internal controls, drives digital and systems transformation, and serves as the primary liaison with government agencies and regulators.

This position reports the Vice President of Strategic Soucing, Procurement and Supplier Quality and is based in Irvine, CA.

As the Director of Strategic Trade Compliance, you will have the following key responsibilities:

Strategy, Leadership & Governance

• Define and execute the global trade compliance strategy across import, export, and sanctions.
• Serve as a trusted advisor to executive leadership, delivering insights on trade risk, regulatory changes, and cost optimization.
• Lead, develop, and scale a global or regional team of trade compliance professionals.
• Establish and govern enterprise trade compliance policies, procedures, and internal control frameworks.
• Monitor global legislative and regulatory developments (Customs, ITAR, EAR, OFAC, trade remedies) and guide proactive business response.

Import Compliance (Core Expertise)

• Oversee global import compliance programs ensuring accurate customs declarations, documentation, and controls.
• Act as subject matter authority on tariff classification, valuation, country of origin, and partner government agency requirements.
• Optimize use of Free and Preferential Trade Agreements (FTAs) and duty-savings programs.
• Govern Foreign Trade Zone (FTZ) compliance and operations, including CTPAT, Importer Self-Assessment (ISA), Duty Drawback, and Reconciliation.
• Manage exposure to trade remedies and regulations, including IEEPA, Sections 232 & 301, antidumping, and countervailing duties.
• Partner with customs brokers and government agencies to resolve audits, inquiries, and compliance issues.

Export Compliance (Advanced Working Knowledge)

• Oversee export compliance programs aligned with ITAR, EAR, and Foreign Trade Regulations (FTR).
• Lead jurisdiction and classification determinations (USML/CCL).
• Manage export licensing and authorizations, including DSP-5 licenses, TAAs, and Commerce licenses.
• Oversee export authorizations through DECCS and SNAP-R.
• Govern deemed export controls, technology control plans, and end-use/end-user/destination restrictions.
• Deliver training and guidance to internal stakeholders on export control requirements.

Sanctions & Restricted Party Compliance

• Govern OFAC sanctions compliance, including restricted party screening and beneficial ownership due diligence.
• Ensure effective screening tools, escalation protocols, and recordkeeping processes are maintained.

Risk Management, Audits & Regulatory Engagement

• Lead internal audits, compliance assessments, investigations, and remediation activities.
• Manage voluntary disclosures and regulatory communications with CBP, BIS, DDTC, and OFAC.
• Represent the company in regulatory matters, audits, and industry associations.

Systems, Data & Transformation

• Drive automation and digital enablement of trade compliance processes.
• Lead enterprise trade system initiatives (e.g., SAP S/4HANA, SAP GTS, Descartes), including design, implementation, and governance.
• Leverage ACE trade data, dashboards, KPIs, and analytics to monitor performance and risk.
• Manage large-scale programs and budgets, ensuring timely delivery, adoption, and sustained outcomes.

Cross-Functional Collaboration

• Partner with Supply Chain, Sourcing, Legal, Engineering, Finance, Tax, IT, Logistics, and Procurement teams.
• Advise business leaders on sourcing strategies, product design, distribution models, and market entry decisions.
• Embed trade compliance requirements into enterprise processes and systems.

You have:

• Experience: 10+ years of progressive experience in international trade compliance within a multinational organization, global consulting firm, or law firm.
• Education: Bachelor’s degree in International Business, Law, Supply Chain, Logistics, Engineering, or related field.
• Licensed Customs Broker (LCB).
• Regulatory expertise in customs and import compliance (core), export controls under ITAR and EAR and OFAC sanctions compliance
• Leadership: Demonstrated success leading global or matrixed teams and enterprise compliance programs.
• Systems Knowledge: Experience with enterprise trade systems (e.g., SAP GTS, Descartes), ACE Portal, and government platforms (DECCS, SNAP-R).
• Skills: Strong analytical, communication, and executive stakeholder management capabilities.

You might have:

• Advanced degree (MBA, MS, JD, or LL.M. in International Trade).
• Experience managing compliance or transformation initiatives exceeding $1M in budget.
• Industry experience in manufacturing, industrial products, applied sciences, consumer goods, or regulated industries.
• Prior leadership of major ERP or digital trade transformations.

OUR COMPANY:

DISPLAYIT Inc. stands as an acclaimed designer and manufacturer, specializing in the creation of structured experiential environments. Established in 1998 in Irvine, California, currently expanding operation in Texas. DISPLAYIT is dedicated to designing, constructing, and installing innovative structural branded solutions that convey a cohesive brand message for our valued customers.

At the heart of our success is a team of highly talented individuals who collaborate creatively at the highest level, aiming to deliver the finest custom experiences. Our commitment is underscored by our relentless pursuit of creative solutions to exceed customer expectations. We exist not only to meet but to surpass the needs of our customers, and our unwavering focus is on operational efficiency.

Join us in our journey at our state-of-the-art facilities located in the vibrant city of Irvine, where innovation and excellence converge.

SUMMARY:

The additional Technical Draftsperson will play a key role in our engineering department, collaborating closely with the design, fabrication, and project management teams to translate conceptual design into well-coordinated, technically accurate construction documents. This role requires a firm grasp of fabrication methods, architectural detailing, industry standards, and a proactive approach to problem-solving. The selected candidate will contribute to projects across the entire design-to-fabrication spectrum, ensuring precision, efficiency, and adherence to project timelines. Under the direction of the Project Manager and Director of Design/Technology, the 3D Technical Designer/Drafter produces shop drawings for multiple elements or entire projects. The ideal candidate must possess excellent technical design skills and some leadership skills to develop and implement solutions and communicate them to stakeholders effectively.

DUTIES AND RESPONSIBILITIES:

• Develop detailed shop drawing packages and architectural drawings, including plans, elevations, sections, and details, to provide clients, project managers, and fabrication leads with an accurate representation of the design intent, scope of work, materials, and fabrication/assembly methods.
• Collaborate with the design team to ensure seamless integration of aesthetic and functional aspects into technical drawings. Proactively identify potential design and fabrication issues and propose solutions.
• Meet deadlines and achieve high-quality, on-budget outcomes by establishing and maintaining effective communication among the project team, fabricators, clients, vendors, contractors, and consultants.
• Conduct thorough reviews of technical documents to ensure accuracy, completeness, and compliance with industry standards and regulations.
• Implement best practices and standards to accelerate project timelines while maintaining quality.
• Ensure the design complies with company standards, client requirements, and other specifications (ADA, Building Codes, etc.)
• Prepare facility impact documentation to share with the architect, client, and general contractors, detailing the necessary infrastructure to integrate and install the exhibit.
• Identify opportunities for process optimization and efficiency improvements within the design and engineering workflow. Utilize relevant software tools and platforms to enhance the efficiency and accuracy of fabrication drawings.

QUALIFICATIONS:

• Associate or Bachelor’s Degree in Engineering, Architecture Industrial Design, Interior Design, or other related Design/Engineering specialization preferred.
• Minimum of 5-10 years of post-college experience as a drafter/detailer for one or more of the following fields: Cabinetry/Millwork, Furniture, Retail, Hospitality, Commercial Architecture, Museum, Trade Show Exhibits, Theater, and Amusement Park projects.
• Proficiency in 2D/3D Design in Rhino or a willingness to learn it within a few months of starting.
• Exceptional proficiency in at least one of the following programs: Rhino, AutoCAD, Fusion, Inventor, SolidWorks, SketchUp, Vectorworks, ArchiCAD, and Revit.
• Strong knowledge of materials/finishes, fabrication tools, and techniques to develop highly detailed 3D models, fabrication drawings, and assembly instructions supporting the design/manufacturing process.
• Strong analytical and problem-solving skills
• General knowledge of building design and documentation
• Fabrication experience is a plus.
• Ability to effectively communicate verbally and in writing, as well as interpret verbal and written instructions.
• Ability to manage multiple projects and drawings simultaneously with attention to detail.
• Ability to prioritize and meet deadlines with limited supervision.
• Experience designing or programming for CNC and Laser Cutting Machines preferred.
• Working knowledge of Microsoft Office Suite, PDF editors, and other support software.
• Bilingual in Spanish/English is a plus.

COMPETENCIES

• Problem Solving--Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
• Written Communication--Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
• Customer Service--Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments.
• Adaptability--Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

• Frequently required to stand
• Frequently required to walk
• Frequently required to sit
• Frequently required to utilize hand and finger dexterity
• Frequently required to talk or hear
• Occasionally required to lift/push/carry items that may exceed 35 pounds

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Work setting:

• In-person
• Office

Department

Research & Development (R&D)

Summary

nRichDX is seeking an R&D team member whose primary responsibility will be quality control and functional testing of nucleic-acid extraction kits (cfDNA/cfRNA/cfTNA/CTC-related), supporting product releases and manufacturing scale. This role will also contribute to routine R&D workflows, including method verification, troubleshooting, documentation, and data generation for continuous improvement and external deliverables.

Key Responsibilities

Kit QC & Functional Testing (Primary)

• Own and execute functional testing plans for commercial kit lots (incoming components, in-process, and final kit performance testing).
• Run routine QC assays, including (as applicable):
• qPCR/RT-qPCR (recovery, inhibition checks, linearity)
• TapeStation/Bioanalyzer (size profiles, integrity, yield QC)
• Fluorometric quantification (Qubit/PicoGreen/RiboGreen)
• Extraction performance checks (yield, reproducibility, carryover, contamination controls)
• Prepare and process biological samples (plasma/urine/whole blood and contrived controls) according to SOPs.
• Track lot performance, generate QC summaries/CoA-support data, and flag out-of-spec trends.
• Investigate deviations and failures, perform root-cause analysis, and recommend corrective actions with R&D, Manufacturing, and Quality.

Cross-Functional Support

• Partner with Manufacturing to ensure smooth tech transfer and readiness for scale (materials, build records, test readiness).
• Coordinate with Quality on documentation, change control support, and release criteria.
• Support troubleshooting of customer-reported issues by recreating conditions and documenting findings.

Routine R&D Work (Secondary)

• Assist with protocol optimization, method verification, and robustness studies.
• Support automation workflows as needed (e.g., Hamilton or internal platforms), including run setup, execution, and data review.
• Maintain lab organization, instrument upkeep, reagent preparation, and inventory management.
• Maintain high-quality documentation: lab notebooks, raw data files, SOP updates, and summary reports.

Qualifications

Required

• B.S. in Molecular Biology, Biochemistry, Chemistry, Biomedical Engineering, or related field (M.S. preferred).
• 2+ years hands-on experience in a molecular biology lab (industry preferred).
• Demonstrated experience with DNA/RNA extraction and qPCR/RT-qPCR.
• Strong attention to detail and comfort working in a structured, repeatable testing environment.
• Ability to produce clear documentation and communicate results to cross-functional teams.

Preferred

• Experience with cfDNA/cfRNA/cfTNA workflows, low-input samples, or liquid biopsy.
• Experience with TapeStation/Bioanalyzer, NGS library QC, or inhibition/contamination control strategies.
• Familiarity with GxP/ISO concepts, change control, deviations, and data integrity principles.
• Experience supporting automation platforms (Hamilton, etc.).
• Comfortable analyzing data in Excel; bonus for basic stats/graphing or scripting.

Skills & Attributes

• Highly organized, reliable, and execution-focused.
• Strong troubleshooting mindset and ability to identify patterns/trends across lots.
• Collaborative and comfortable working with R&D, Manufacturing, and Quality.
• Able to manage multiple tests/priorities while maintaining accuracy.

Working Conditions

• Lab-based role handling human-derived specimens (with appropriate training and PPE).
• May require occasional schedule flexibility to support builds, releases, or time-sensitive studies.

Success Metrics (First 3–6 Months)

• Independently executes the functional testing plan for kit lots with minimal supervision.
• Produces consistent, audit-ready QC documentation and summaries.
• Helps reduce retests/failures via early detection of issues and clear root-cause investigations.
• Contributes meaningfully to routine R&D studies and continuous improvement efforts.

Leapros is a trusted workforce solutions partner, offering customized recruitment and interim staffing solutions, as well as innovative resources designed to empower employers and professionals to accomplish their hiring and career objectives. Operating on a national platform, our areas of concentration include finance and accounting, information technology and engineering, human resources and administration, sales and marketing, supply chain and operations. Whether you are a talented professional or a company looking for a talented professional, we welcome you to take a leap with us!

CLIENT PARTNER PROFILE & VALUE PROPOSITION: Leapros has been engaged by nationwide real estate investment company to fill a Division HR Generalist role. This is an exciting opportunity to make a big impact with a growing organization in Orange County, CA!

POSITION TITLE: Senior Human Resources Generalist

POSITION SUMMARY: The Senior Human Resources Generalist will be responsible for all day-to-day human resources functions within a designated region with the Company. Providing support for all levels of human resources needs for all levels of staff within the assigned districts.

RESPONSIBILITIES/DUTIES:

• Processes all requests for store-level new hires and terminations, including but not limited to offer letters; background checks; communications between hiring managers and field staff members and corporate level staff members; and all necessary internal forms within their designated region(s) within the Company.
• Processes and manages all leaves of absence and workers compensation claims within their designated districts.
• Serves as the primary contact for all HR related questions for all field staff within their assigned region(s).
• Provides guidance and support to the Regional and District Managers within their assigned region(s).
• Processes, reviews and responds to unemployment and workers comp claims with appropriate documentation. Review unemployment statements.
• Performs technical and professional level management support functions in the daily administration of all human resource services.
• Maintains compliance with federal, state, and local employment laws and regulations, and recommends best practices; reviews policies and practices to maintain compliance.
• Maintains knowledge of trends, best practices, regulatory changes, and new technologies in human resources, talent management, and employment law.
• Handles employment-related inquiries from applicants, employees, and managers, referring complex and/or sensitive matters to the appropriate staff.
• Serves as the subject matter expert to the field employees on all HR related software and platforms.
• Manages and maintains the integrity of the HRIIS systems, routinely running reports and audits to ensure the highest level of data accuracy.
• Provides an example of possessing the Company’s core values and consistently fosters a positive and inclusive work environment.
• This position may provide mentoring of junior staff members with the People & Culture Department.

QUALIFICATIONS:

• Bachelor’s degree in human resources, Business Administration or a related field required.
• At least 5 years of human resources generalist experience in multi-site/multi-state organizations required.
• SHRM certification a plus.
• Excellent verbal and written communication skills.
• Excellent interpersonal, negotiation, and conflict resolution skills.
• Ability to prioritize tasks and to delegate them when appropriate.
• Ability to act with integrity, professionalism, and confidentiality.
• Thorough knowledge of employment-related laws and regulations.
• Proficient with Microsoft Office Suite or related software.
• Proficiency with the Company’s HRIS and talent management systems.

PAY TRANSPARENCY: A reasonable estimate of the available {annual or hourly} pay scale for this position is: $85,000-$95,000 per year plus bonus. The actual compensation offered may vary depending on qualifications and other factors essential to the performance of duties and is determined by the hiring authority.

At Leapros, we are committed to our core values and guiding ethical principles, to conducting business in a non-discriminatory manner, and to operating in strict compliance with applicable federal and state laws pertaining to Equal Employment Opportunity. This commitment enhances our ability to conduct business with the highest level of integrity, solidifying our position as the most trusted workforce solutions partner. To learn more about Leapros or to speak with one of our recruitment partners, call 866-920-LEAP or visit our website at

Materials Planner II

Broadband Telcom Power is an EV charging equipment manufacturing company focused on delivering reliable power solutions that support the future of electric mobility. We are seeking a Materials Planner II to support field service parts planning and new product material readiness. This role plays a key part in ensuring service material availability, inventory optimization, and strong customer support performance.

Job Summary

The Materials Planner II supports planning and purchasing activities for field service materials and new product introductions. This position partners closely with customer service, supply chain, and engineering teams to maintain inventory balance, support production demands, and proactively manage material risks.

Responsibilities

• Plan and purchase field service parts for key customers, partnering closely with customer service to minimize shortages while meeting service-level expectations

• Manage and balance Vendor Managed Inventory (VMI), including monitoring demand trends, failure rates, recall events, and customer requests

• Ensure all part substitutions are properly communicated, documented, and approved by customers as required

• Review forecasts and develop long-term material planning strategies to support field service and production needs

• Drive purchasing activity to support demand for field service or production materials

• Maintain appropriate inventory levels of raw materials and NPI finished goods through product development and release stages

• Track production volume and monitor customer demand patterns to proactively address supply risks

• Perform excess and obsolete (E&O) analysis, prepare inventory reports, and lead E&O review discussions with clear recommendations

• Manage inventory challenges including schedule changes, cancellations, and material constraints

• Prepare and publish cost estimates, inventory reports, and KPI updates

• Proactively escalate and resolve material challenges with internal teams and external customers while balancing service and business priorities

Qualifications / Requirements

• Bachelor’s degree in Business or a related field

• Minimum of 4 years of experience in an electronics manufacturing environment

• Strong analytical and problem-solving skills

• Advanced proficiency in Microsoft Excel and PowerPoint

• Strong communication skills with the ability to work across all levels of the organization

• Ability to manage multiple high-priority projects in a fast-paced environment

• Self-motivated and able to work independently with clear goals and accountability

• Strong collaboration skills and experience working with cross-functional teams, including remote teams

• Demonstrated initiative and ability to drive resolution of material and inventory issues

Benefits

• Holiday Pay and Paid Time Off

• Medical, Dental, Vision, Life and AD&D Insurance

• 401(k) Retirement Plan with Company Match

• Opportunity to grow and develop professionally

EEO Statement

Broadband Telcom Power provides equal employment opportunities to all employees and applicants and prohibits discrimination and harassment of any kind in accordance with applicable federal, state, and local laws.

The work we take on across Orange County tends to come from long standing relationships and negotiated opportunities rather than chasing every job that appears. As a regional builder, our focus has always been steady project delivery and building trust with the owners and consultants we work with year after year. That approach has created a strong backlog of negotiated projects across a wide variety of sectors including multifamily, office, tilt-wall industrial, retail, medical, and other commercial developments, allowing our teams to stay focused on building well rather than constantly chasing the next project.

Equally important to us is the kind of workplace we have built over time. People here tend to stay because they enjoy the environment and the people they work alongside. The teams are collaborative, experienced leaders make time to mentor others, and there is a genuine sense of pride in the projects we deliver together. We try to maintain a culture where professionals can do meaningful work, support one another, and continue growing in their careers.

What this role will involve

• Overseeing commercial construction projects from early planning through completion

• Monitoring project financial performance including budgets and forecasting

• Working closely with Superintendents to keep field operations aligned with the plan

• Maintaining steady communication with owners, architects, and consultants

• Coordinating subcontractor procurement and scope management

• Keeping project documentation organized including RFIs, submittals, and change management

What typically leads to success in this position

• 5+ years working with a reputable commercial General Contractor

• Experience helping manage commercial construction projects

• Comfort reviewing project budgets, schedules, and contracts

• Ability to maintain productive working relationships with clients and consultants

• Construction Management, Engineering, or related degree is helpful but not required

Our projects serve the greater Orange County region, including Newport Beach, Anaheim, Orange, Santa Ana, Costa Mesa, Laguna Beach, Laguna Niguel, and Mission Viejo, and we enjoy working with professionals who live and build in these same communities.

If this sounds like something worth discussing, apply here on LinkedIn, contact one of our associates, or visit our website and complete the short form so we can schedule a conversation and share more details.

Kelly® Science & Clinical is seeking a Quality Assurance Validation Specialist for a contract position at a premier pharmaceutical client in Irvine, CA If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Empowering Experts.

Job Title: QA Validation Specialist (Contract)

Duration: 10 months

Location: Irvine, CA (onsite)

Rate: $38–40/hr.

This position involves hands-on ownership of equipment, facility, and laboratory validations. Ideal for experienced validation professionals who excel in regulated environments and enjoy driving projects from protocol development through audit-ready execution.

RESPONSIBILITIES:

• Assists in assuring facility, manufacturing, packaging, and Laboratory equipment are qualified to the required cGMP standards.
• Authors/approves and executes qualification protocols and reports.
• Schedules, plans, manages performance qualifications, calibration and maintenance of equipment and utility systems and laboratory Instruments in coordination with operations, Quality Control and maintenance.
• Assists sourcing and procurement of facility equipment and Laboratory Instruments through completion of following tasks
• Qualification of Vendors Selected.
• Input to the development of the URS/FRS/DDS.
• Assists with the routine calibration and maintenance of the Validation Master Plan for the site.
• May present qualification studies to Regulatory and Client Auditors as required.
• Assists with the design, maintenance, and continual improvement of the qualification system in line with cGMP standards.
• Provides technical expertise and guidance on qualification policies and procedures and the implementation of those within the Production and Quality functional areas.
• Occasionally supervises specialized contract personnel and outside vendors in the performance of contract services.
• Summarizes studies and authors qualification reports in compliance with the cGMP standards and in a timely manner.
• Develops and executes matrix type validations where applicable for processes and equipment with adequate supporting rationales.
• Initiates and investigates exception reports and non-conformances, associated with the qualification studies. Troubleshoots and resolves technical issues.
• Other responsibilities and special projects will be assigned based on business and customer needs.

QUALIFICATIONS:

• Bachelor’s degree in Sciences
• 5+ year’s of experience in a highly regulated pharmaceuticals industry or related field
• Strong working knowledge of cGMP and regulatory standards for validation.
• Experience in writing and reviewing SOPs, GMPs, governmental regulations and/or protocols for accuracy, traceability and compliance.
• Demonstrated experience with qualification of commercial processing a packaging equipment.
• Proven track record of managing projects from start to finish on time and on budget.

What happens next:

Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

Are you an experienced Electrical Engineer with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Electrical Engineer to work at their company in Irvine, CA.

Primary Responsibilities/Accountabilities:

• Identifying gaps in the acquired company's compliance with Work Instructions and SOPs and defining a strategy to close these gaps.
• Providing input to project goals and progress, and recommending appropriate revisions.
• Communicating progress, risks, and trade-offs of technical deliverables to project leadership and recommending revisions as needed.
• Completing complex or Client assignments requiring the development of new or improved techniques and procedures. Work is expected to result in efficient and effective integration of medical device technologies to the portfolio.
• Successfully completed engineering work in electrical design remediation, product design refinement, preparation of specifications, test method validation, and report preparation.
• Assessing the feasibility and soundness of alternative engineering processes, products, or equipment.
• Completing clear and concise engineering documentation.

Qualifications:

• Electrical Engineer degree - firm, with 4+ years of experience
• Must have medical device experience
• Implantable medical device experience and testing
• Strong electrical and/or systems engineering design documentation experience, problem-solving skills and attention to detail
• Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources
• Strong written and verbal communication, judgment, decision-making, collaboration, and critical thinking skills
• Personal drive, individual accountability & a strong bias for action.
• Up to 10% travel -mostly local.

Preferred:

• Familiarity with IEC 14708 and 45502 Active Implantable standards
• Familiarity with IEC 60601 Electrical Medical Equipment standards
• Experience in Altium and/or LT Spice
• Experience in medical device design, acceptance, and Design Verification testing
• Ability to build strong relationships across the organisation and with external stakeholders

Sr Specialist, Clinical Development

Duration - 8 Months

Location - Irvine, CA

Pay Rate:- $55.00-$66.92/hour, depending on experience

Ensures product development includes all necessary clinical input and aspects for the best interest of patients and utility for treating physicians.

Key Responsibilities:

*Ensure successful product lifecycle management, from early human use through commercial submission

*Develop and implement pre-clinical test strategy and provide guidance to team members on execution strategy

*Provide scientific rationale for product attributes and pre-clinical test results

*Provide product and procedural expertise for new product development as well as introduction training for clinical and site personnel

* Develop, review, and update clinical design control documents including providing advice and guidance to product development team on development of technical summaries, clinical risk assessments, product training, instructions for use, design of validation protocols and reports, usability protocols and reports, design and application of FMEAs (Failure Modes and Effects Analysis), for technical and clinical documentation in product development.

* Ensure procedural, medical and scientific factors are considered during cross-functional product development project team meetings.

* Design, review and/or conduct literature searches and complete literature reviews for design concept, product development, protocol preparation, clinical risk assessments and/or clinical evaluation reports

* Consult with field personnel to gather field device performance feedback, as well as to ensure national and country clinical/regulatory requirements compliance.

* Evaluate collected data documentation and imaging media, draw findings, make recommendations, and provide advice and guidance to complete product evaluations, product complaint review and other required interim or final reports.

*Analyze data to support clinical trial safety investigations and new product development

*Other duties as assigned by leadership

Education and Experience:

Bachelor's Degree in biology or lifesciences field, 5 Years years experience Class II and III medical device technologies and/or clinical studies background Required

Bachelor's Degree in engineering Preferred

Additional Skills:

* Proven expertise with computer skills - Microsoft Office (Word, Excel, Project, PowerPoint), Outlook, Internet

* Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery

* Experience with pre-clinical testing protocols, hospital environments and sterile techniques

* Data analysis skills, with understanding of statistical analysis techniques

* Good communication and organizational skills

* Excellent written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skills

* Full knowledge of US and international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)

* Demonstrated problem-solving and critical thinking skills

* Thorough, conscientious and results oriented working style

* Team oriented

* Ability to work in a dynamic work environment

* Knowledge of US/international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).

* Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

* Experience in TMVR and/or fluroscopic and echocardiographic imaging preferred

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.