Engineering Jobs in Hayward

Straive is a global leader in enterprise-grade data analytics and AI solutions, committed to empowering businesses across various industries with cutting-edge technology and expert insights. Backed by EQT, a top private equity firm, we are uniquely positioned to drive innovation through significant investments and an entrepreneurial spirit.

Our core focus is on delivering advanced Data Analytics & AI Solutions. By combining sophisticated technology with subject matter expertise, we deliver material impact on our clients' topline and streamline their operations. We specialize in providing tailored solutions across financial services, CPG, legal, pharma, life sciences, retail and logistics, helping them build robust data analytics and AI capabilities.

With a client base spanning 30 countries, Straive's strategically located teams operate from eight countries and is headquartered in Singapore. This global presence enables us to offer localized expertise with a worldwide perspective.

Join Straive to be part of a dynamic team at the forefront of data analytics and AI innovation. Here, you'll have the opportunity to contribute to transformative projects, supported by significant investments and an entrepreneurial drive fueled by our partnership with EQT.

Website: Title: Account Manager - Tech & Media Vertical

Location: West Coast, USA

Job Type: FTE

Role Overview

We are seeking an experienced Account Manager to own and grow key West Coast accounts in the Tech & Media vertical. This role sits at the intersection of data, analytics, AI, technology, and operations, partnering with leading technology platforms, media companies, and digital-first brands to drive measurable business outcomes.

You will be responsible for end-to-end account management: relationship development, solution adoption, commercial growth, and cross-functional coordination to ensure exceptional delivery.

Key Responsibilities

Account Ownership & Growth

• Serve as the primary point of contact for a portfolio of West Coast Tech & Media clients.
• Develop and execute strategic account plans focused on retention, expansion, and upsell/cross-sell opportunities.
• Meet or exceed revenue, renewal, and growth targets for assigned accounts.
• Identify new business opportunities within existing accounts, including new use cases for data, analytics, AI, and technology solutions.

Client Relationship Management

• Build strong, trusted advisor relationships with senior stakeholders (e.g., Marketing, Product, Data/Analytics, Operations, IT).
• Lead regular business reviews, performance updates, and strategic planning sessions.
• Proactively manage client expectations, resolve issues, and ensure high levels of satisfaction and advocacy.

Solution & Value Delivery

• Deeply understand our data, analytics, AI, and technology offerings and how they apply to Tech & Media use cases (e.g., audience insights, content optimization, ad performance, personalization, operational efficiency).
• Translate client business objectives into solution roadmaps and measurable KPIs.
• Partner with internal teams (Product, Data Science, Engineering, Operations, Professional Services) to ensure successful onboarding, implementation, and ongoing optimization.
• Analyze performance data and provide actionable insights and recommendations to clients.

Operational Excellence

• Maintain accurate account plans, forecasts, and pipeline in CRM and reporting tools.
• Coordinate contract renewals, SOWs, pricing discussions, and commercial negotiations.
• Ensure timely and high-quality delivery of projects, reports, and services.
• Gather client feedback and market intelligence to inform product roadmap and go-to-market strategies.

Qualifications

Required

• 4–7+ years of experience in account management, client success, or strategic partnerships, preferably in:
• Ad tech / martech
• Media & entertainment / streaming
• SaaS / data & analytics / AI platforms
• Proven track record of managing and growing enterprise or strategic accounts.
• Strong understanding of data, analytics, and/or AI-driven solutions and how they impact business performance.
• Experience working with cross-functional teams (sales, product, data/analytics, operations, engineering).
• Excellent communication, presentation, and storytelling skills, with the ability to simplify complex technical concepts for business stakeholders.
• Strong analytical skills; comfortable working with dashboards, reports, and performance metrics.
• Based on or able to work effectively with clients across the US West Coast time zone.

Preferred

• Experience with major Tech & Media companies (e.g., platforms, publishers, streaming services, gaming, digital content).
• Familiarity with digital advertising, audience measurement, attribution, or marketing analytics.
• Experience with CRM tools (e.g., Salesforce), BI tools (e.g., Tableau, Looker, Power BI), and collaboration tools (e.g., Slack, Jira).
• Bachelor’s degree in Business, Marketing, Communications, Data/Analytics, or related field; MBA or equivalent experience a plus.

Key Competencies

• Client-centric mindset and strong relationship-building skills
• Commercial acumen and negotiation skills
• Strategic thinking with the ability to connect data and technology to business outcomes
• Problem-solving and issue resolution under time pressure
• High ownership, accountability, and follow-through
• Ability to work independently and collaboratively in a fast-paced, evolving environment

This job description is not intended to cover or contain a comprehensive listing of all responsibilities, duties, or activities that are required. Responsibilities, duties, and/or activities may change, or new ones may be added at any time with or without notice.

If you are a motivated professional with a passion for delivering impactful solutions, we’d love to hear from you. Apply today to be part of a dynamic and forward-thinking team at Straive.

“Straive is an Equal Opportunity Employer. Our policy is clear: there shall be no discrimination based on age, disability, sex, race, religion or belief, gender reassignment, marriage/civil partnership, pregnancy/maternity, or sexual orientation.

We are an inclusive organization and actively promote equality of opportunity for all with the right mix of talent, skills and potential. We welcome all applications from a wide range of candidates. Selection for roles will be based on individual merit alone.”

Position Title: Quality Manager

Immediate Supervisor: Executive Owner

General Purpose: This key leadership position is responsible for leading all aspects of Quality processes and systems, managing the Quality Management System (QMS), internal and external audits, regulatory and safety compliance, and leading a team of Quality Technicians, Process Engineers and Learning and Development Coordinators in a manufacturing environment. The role collaborates with cross-functional teams to drive continuous improvement, ensure product integrity, and exceed customer expectations. This role is with a small, family-owned contract manufacturing company that is rapidly expanding, fueled by New Product Introductions and the development of full-scale production capabilities.

Responsibilities:

QUALITY MANAGEMENT

Customer Response Team:

• Serve as the primary point of contact for quality-related communications with customers and suppliers.
• Manage customer complaints, lead investigations, and coordinate timely, effective resolution.

Manage ISO Certification

• Maintain the Quality Management System (QMS) in compliance with ISO 13485 and applicable customer/regulatory requirements.
• Own Document Control for QMS and production documents (Work Orders, labels, Certificates of Conformance, inspection forms), ensuring revision control, approvals, controlled release, and record retention.
• Lead internal and external audits (customer, supplier, registrar), including audit preparation, execution, follow-up, and reporting to the Executive Team.
• Own the metrology and test equipment program (calipers, gauges, vision systems, clean room monitoring equipment, etc.), including calibration/verification, status control, and records management.
• Oversee equipment qualifications and process validations to ensure ongoing compliance and product integrity.

Manage Quality Assurance Processes

• Drive robust Root Cause Analysis and CAPA execution for internal and external nonconformances.
• Lead and develop the Quality team, including supervision of Quality Technicians and daily quality execution on the production floor.
• Manage supplier quality performance, including supplier evaluations, audits, incoming quality issues, and nonconformance resolution.
• Maintain clean room quality standards, environmental controls, and monitoring/testing protocols.
• Assess quality organizational needs and build a high-performing team aligned with business growth and customer requirements.

CONTINUOUS IMPROVEMENT

• Lead and oversee the company’s Continuous Improvement (CI) program to drive process optimization, quality performance, and operational excellence.
• Partner cross-functionally to identify improvement opportunities, implement solutions, and sustain gains.
• Partner with company leadership to define quality strategy, establish KPIs, and drive continuous improvement.
• Evaluate and implement best practices, tools, technologies, and systems that strengthen quality, compliance, and manufacturing capability.
• Develop, maintain, and enforce manufacturing SOPs, work instructions, and standard work to ensure consistent execution and training alignment.
• Identify and mitigate operational risks affecting product quality, safety, delivery performance, and regulatory/customer compliance.
• Manage organizational safety programs, including compliance with the IIPP (Injury and Illness Prevention Program) and related safety requirements.

LEARNING AND DEVELOPMENT

• Lead and oversee company-wide training and employee development programs, including the implementation, development, and leadership of quality- and safety-related training, to support performance, compliance, and organizational capability, and ensure employees are competent to perform assigned duties and meet QMS requirements.
• Administer the Learning Management System (LMS), maintaining current training content, training matrices, and complete/accurate training records to support audits and continuous improvement.

Education / Experience:

• Bachelor’s degree in a quality, manufacturing, engineering, or medical device related field.
• 4+ years in a Quality leadership role within a manufacturing environment.
• 3+ years managing a QMS within ISO 13485 or other ISO Standards within a manufacturing environment, and leading customer/supplier audits.
• Proven experience with precision component manufacturing and contract manufacturing environments.
• Hands-on experience with CAPA, root cause investigations, and quality metrics.
• Familiarity with medical device manufacturing and regulated industries (Preferred).
• Familiarity with applying principles of Lean Manufacturing, Theory of Constraints and/or Six Sigma Problem Solving.

Qualifications:

• Proficient in interpreting engineering drawings and using inspection equipment.
• Strong organization and communication skills; experience delivering training.
• Comfortable working independently and leading small teams.
• Ability to effectively serve as the primary point of contact for all quality-related communications.
• Aptitude for working within a small family business environment where responsibilities and priorities can change quickly.
• Spanish-speaking ability (Preferred).
• Must be available for full-time, on-site work in San Carlos, CA.

Physical demands:

• Combination of office and plant production floor presence for supervision, inspections, and clean room management.
• Ability to sit at a desk for periods of time for planning and reporting.
• Ability to stand and walk for extended periods on the plant floor.
• Operate standard office equipment and hand controls.
• Ability to occasionally lift up to 20 pounds (e.g., supplies, production files).
• Observe visually distance, color, periphery and depth; ability to adjust focus.

What We Offer: 

• Full time permanent role with competitive salary and benefits (medical, dental, vision, 401(k) + matching)
• $110,000 - $140,000 per year
• Opportunity to grow within a technically advanced converting business working with top-tier customers and materials

**Disclaimer: This job description may not be inclusive of all assigned duties/responsibilities or aspects of the job, and additional duties/responsibilities may be assigned from time to time as necessitated by business demands and/or operational considerations at the sole discretion of the Employer. This job description does not constitute a contract of employment and the employment relationship between Employee and Employer is at-will.

We are hiring Full-Stack Enterprise AEs who can own the entire revenue cycle — from prospecting to closing and expansion.

This is not a traditional “wait for SDR handoff” role.

You will operate as a self-sufficient seller empowered with:

• FlashRev list-building
• AI SuperAgent
• Parallel Dialer
• AI Meeting Agent
• Automated workflows

Your Mission:

Land and expand 6–7 figure deals with U.S. and global enterprise customers.

You will sell FlashLabs’ AI GTM automation to:

• Fintechs (payments, wallets, neobanks)
• Insurtech
• Lending & BNPL platforms
• Brokerages & wealth tech
• Exchanges
• Compliance-driven fintech teams

Key Responsibilities

• Own the full sales cycle: from ICP targeting → outbound → qualification → demo → proposal → close → expansion.
• Conduct high-impact discovery with VPs, C-suite, and transformation teams.
• Deliver tailored demos of FlashLabs SuperAgent, FlashAI Voice, FlashRev, and AIFlow.
• Use our AI outbound engine + self-sourced pipeline to drive meetings.
• Conduct intelligent prospecting (email, LinkedIn, phone, AI agents).
• Build and maintain a strong top-of-funnel independently.
• Lead multi-threaded enterprise sales cycles (6–12 weeks).
• Handle InfoSec, legal, procurement, and compliance reviews.
• Build ROI, business cases, and transformation proposals.
• Drive land-and-expand motions across teams, departments, and regions.
• Partner with CS to ensure adoption and value realization.
• Grow accounts into multi-year, high-ACV partnerships.
• Become a domain expert in AI GTM automation.
• Relay product feedback to engineering to guide the roadmap.
• Represent FlashLabs at industry events, webinars, and executive briefings.

Responsibilities:

• Ensure all design control activities for new and updated products meet company procedures and global regulatory requirements.
• Lead risk management activities, including hazard analysis, FMEAs, and risk documentation.
• Support sterilization and biocompatibility assessments.
• Own and maintain design control documentation.
• Partner with R&D, Regulatory, Manufacturing, and Project Management to ensure quality is built into every stage of product development.
• Maintain accurate test, validation, and risk records and report progress to leadership.
• Support regulatory submissions (e.g., 510(k), CE Mark).
• Lead root cause investigations and corrective actions related to design issues.
• Support complaint investigations, nonconformances, and CAPAs after product launch.
• Conduct DHF audits to ensure phase completion requirements are met.
• Review and approve engineering documents and test reports.
• Identify opportunities to improve product quality, reduce cost, and increase efficiency.

Requirements

• Bachelor’s degree in Engineering or related field.
• 10+ years of quality engineering experience in medical devices, including new product launches.
• Experience with sterilization and biocompatability
• Strong knowledge of design controls, risk management, and medical device regulations (FDA, ISO, IEC).
• Experience with verification & validation (V&V) and FMEAs.
• Strong problem-solving and statistical analysis skills (e.g., Minitab, JMP).
• Detail-oriented with strong documentation skills.
• Quality certifications (CQE, CSQE, Six Sigma) are a plus.

Key Account Manager

Company and Sales Division profile:

Delta Electronics Americas, Ltd is the HQ of Americas Region, focusing on providing power, thermal management, and ODM/JDM networking solutions. Our mission is “To provide innovative, clean, and energy-efficient solutions for a better tomorrow”, focusing on addressing key environmental issues such as global climate change. As an energy-saving solutions provider with core competencies in power electronics, networking infrastructure, and automation, Delta’s business categories include Power Electronics, Mobility, Automation, and Infrastructure.

IT HW Sales Division focuses on providing Account Management and Sales Support to well-known Key High Tech customers with firm footprint in North America. The team focuses on promoting the whole Delta product portfolio to the customers as a one stop shop. On the front end, the team will support customers, including promoting Delta products, following up on customer project requirements, managing project life cycle, providing pre-sales and post sales support, and strengthening the customer relationship. On the back end, the team will work with all the Business Units for product promotion, handling customer escalation, meeting corporate quota and sales guidelines, and bridging the communications between Delta corporate and customers.

Role:

You will be responsible for promoting Delta ODM/JDM solutions, which include servers, storage, and Networking appliances, to customers in Enterprise, Cyber Security, AI, and Semiconductor industries.

You will cooperate with Corporate technical and sales team to acquire new customers while growing the existing accounts with Delta total sales solutions.

You must be able to leverage and combine technical expertise with sales techniques to improve company sales and strengthen good relationship with customers on the front end and Corporate Business units on the back end.

Job Responsibilities/Objectives

Major Responsibilities

Accomplishments/KPI

Collect sales intelligence by understanding the customer applications, competitive analysis, and market trend. Introduce and update Delta roadmap to new customers.

Measure by how many new customers acquired

Provide accurate customer requirements and project scope (RFI/RFQ/RFP) to corporate team to generate proposal and follow up on new opportunities. (Project scope includes project name, application, EAU, schedule, and competition info.)

Measure by how many new projects and opportunities acquired and followed up.

Follow up on new project opportunities, update CRM, and win the projects. Manage NPI project plans and ensure timely delivery of project based deliverables.

Measure by numbers of awarded projects

Drive funnel growth and forecast accuracy across all product lines and accounts. Provide Sales Strategies and Business plan to meet and exceed the assigned quota/budget.

Measure by revenue performance.

Provide Sales Growth to existing accounts and promoting new product division (BG/BU)

Measure by existing account growth over the past 3 years and by number of new product division engagement

Collaborate with Delta design, factory and quality teams to facilitate communication with customers for pre-sales and post sales support.Ensure all customer issues and escalations are resolved in timely manners.

Measure by customer satisfaction feedback as well as corporate feedback.

Key Competencies: (Delta Leadership Qualities/Functional Competencies….)

• Accountability, Reliability, & Responsiveness
• Communications- tailors communication to the customer’s needs; effectively delivers presentations and has good oral and written skills
• Ability to manage multiple customer engagements simultaneously
• Strategic Thinking— develop ways to acquire new customers, grow existing business, and overcoming any customer pushback and problems.
• Ownership— goes out of his way to complete tasks and to achieve results; is independent and self-directed and takes initiative
• Effective Prioritization
• Manage & help to develop other team members while fostering a culture of teamwork and information sharing.

Skills Needed

Analytical & Technical Skills

• Knowledge and expertise in promoting and selling x86 Network appliances, AI Servers, Industrial Ruggedized systems, Switches, WiFi/AP, and Traditional Servers.
• Knowledge about ODM/JDM production process and quality control.
• Ability to understand customer applications and requirements to share with the internal team.
• Ability to manage and drive sales and support services to customers.
• Proficient in reporting tools like Excel, Word, Powerpoint, etc.

Interpersonal & Communication Skills

• Able to set up & build relationship with customers.
• Able to present Delta product, technologies, and capabilities.
• Able to prioritize tasks and respond to each of them individually in a timely manner.
• Able to accept new challenges and learn quickly.
• Good written & verbal communication skills

Job Qualifications

Minimum Requirements

• 5+ years of knowledge and experience in Sales, Business Development, and Product Marketing of Networking appliances, servers, and storage
• 5+ years of Account Management and Sales Support
• Bachelor degree in Computer Science, Engineering, Networking, or Technical Sales related (Preferred)

External:

Who we are:

Delta, founded in 1971, is a global provider of power and thermal management solutions. Its mission statement, "To provide innovative, clean and energy-efficient solutions for a better tomorrow," focuses on addressing key environmental issues such as global climate change. As an energy-saving solutions provider with core competencies in power electronics and automation, Delta's business categories include Power Electronics, Mobility, Automation, and Infrastructure.

About the role:

Junior Account Manager – AI Solutions

Overview

We are seeking a motivated Junior Account Manager to support our growing AI Solutions team. This role is ideal for an early-career professional with a strong technical foundation who is looking to develop hands-on experience in customer engagement, program execution, and AI solution delivery. You will support senior account leads and cross-functional teams to ensure customer success and on-time project execution.

Key Responsibilities

• Support senior account managers in day-to-day customer communication, meeting coordination, and issue tracking.
• Assist with project tracking and reporting, including schedules, action items, risks, and weekly status updates.
• Help document customer requirements, validation plans, and integration schedules.
• Coordinate with engineering, product, data science, and operations teams to support program execution.
• Participate in customer meetings, technical reviews, and PoC activities as a learning contributor.
• Track deliverables, change requests, and documentation updates.
• Support account planning and roadmap alignment activities.
• Operate effectively in fast-paced, multi-timezone environments with multiple concurrent tasks.

Required Qualifications

• Bachelor’s degree in Engineering or a related technical field
• (Electrical, Mechanical, Computer Engineering, or similar preferred.)
• 2 years+ of experience in account management, technical sales, engineering support, or program coordination.
• Strong communication and organizational skills
• (Ability to prepare summaries, track actions, and communicate clearly with internal teams and customers.)
• Detail-oriented and self-motivated
• (Comfortable managing multiple tasks and learning in a fast-changing environment.)
• Basic understanding of technical systems
• (AI, software, data systems, servers, or infrastructure exposure is a plus.)

Preferred Qualifications (Optional)

• Internship or project experience in AI, software, cloud, or data systems
• Exposure to enterprise customers or technical services environments

A leading corporate venture and innovation team at a global mobility firm HQ'd in Asia is hiring an Associate / Senior Associate to help lead early-stage investments and oversee strategic partnerships with high-growth startsup in various sectors including mobility, deep tech, climate tech, AI, robotics, advanced manufacturing and energy.

Please note that this position will begin as a 6 to 12 month contract, with the goal of transitioning to a long term full-time perm hire. The team has a strong track record of converting contractors into full-time roles, and this position is being scoped with long-term fit in mind.

This role sits at the intersection of venture investing, corporate development, and tech integration—ideal for someone who thrives in fast-moving, cross-functional environments and is passionate about emerging technologies. This is a rare opportunity to join a venture group backed by a Fortune Global 100 company — focused not on financial return, but on investing for long-term strategic technology advantage.

Key Responsibilities:

• Source and evaluate early-stage startups (Seed to Series B) across sectors like climate tech, robotics, advanced manufacturing, and AI
• Lead proofs of concept (POCs) and internal pilot projects with engineering and business teams
• Conduct strategic diligence and support investment decisions
• Manage post-investment partnerships and cross-functional implementation
• Coordinate with global stakeholders, including R&D and innovation teams abroad

Candidate Profile:

• 2–7+ years of experience in corporate development, corporate venture capital, VC, innovation, or strategic partnership
• Strong understanding of startups and emerging technology trends
• Technical or engineering background preferred
• Experience with pilot programs, startup collaboration, or venture incubation is a plus
• Comfortable navigating complex organizations and building cross-functional consensus
• Japanese language fluency a strong plus but not required

Technical Manufacturing Sales Representative

The Opportunity

A stealth-mode innovator in AI-driven manufacturing intelligence is scaling its North American sales force. Backed by recent funding and triple-digit growth, the company’s visual-intelligence platform turns any factory camera into a real-time quality, safety, and throughput coach. As a Regional Sales Partner, you will spearhead new-logo expansion across California’s manufacturing corridors - owning both the commercial strategy and the technical conversation that wins trust on the plant floor.

Key Responsibilities

• Drive the entire revenue journey - from prospecting through contract signature- for an industry-leading industrial visual-intelligence solution.
• Lead in-person discovery sessions with plant leadership and C-suite stakeholders, translating production pain points into measurable ROI.
• Deliver live product demos without a dedicated pre-sales engineer, articulating complex concepts in clear business language.
• Build and manage a predictable pipeline through proactive outreach, market mapping, and account planning.
• Travel to customer sites across key California hubs to deepen relationships and accelerate deal momentum.
• Channel field feedback to product and customer-success teams, sharpening go-to-market strategy.

Preferred Qualifications

• 5+ years of quota-carrying success selling technical or industrial SaaS / automation solutions into manufacturing environments.
• Proven record exceeding $1 M+ annual targets in complex, multi-stakeholder deals.
• Comfortable running technical evaluations end-to-end; engineering or automation background a plus.
• Credible on the factory floor - able to engage operators, quality managers, and executives alike.
• Willingness to travel (~25-40 %) throughout the Bay Area or Greater Los Angeles.

Why Join

• Hyper-growth runway: join a sales build-out targeting 50 AEs nationwide over the next 12 months.
• Industry-agnostic impact: current wins in food & beverage and building-materials, with greenfield headroom across all manufacturing verticals.
• Autonomy & influence: shape territory strategy, refine ideal-customer profile, and become the voice of the market internally.
• Competitive 50/50 comp plan (uncapped OTE), full benefits, and rapid path to leadership as regional teams scale.

About Blue Signal [utilize this link to match the role and/or industry]:

Blue Signal is an award-winning, executive search firm specializing in various specialties. Our recruiters have a proven track record of placing top-tier talent across industry verticals, with deep expertise in numerous professional services. Learn more at /46Gs4yS

THE OPPORTUNITY

The Senior Director of Quality Assurance and Regulatory Affairs is a critical member of the leadership team, responsible for establishing and leading the company’s quality and regulatory function, as well as the champion for Moximed’s total quality management system for orthopedic implants and single-use instruments.

This leader oversees all aspects of quality assurance, quality control, regulatory affairs, compliance, and post-market surveillance. They will also guide the regulatory strategy needed to support current commercial products and future pipeline innovations in conjunction with senior management.

The Senior Director will define organizational structure, hire key roles, and foster talent development within the QA and RA department to help ensure successful completion of projects and company milestones in close collaboration with Research and Development, Operations, Sales, Marketing and Clinical Affairs.

This role includes being the Regulatory Affairs team representative for interactions with regulatory bodies, primarily the US FDA and as such will oversee activities related to submissions, registrations and listings, and Medical Device Reporting in cooperation with multiple departments.

WHAT YOU'LL DO

Quality Assurance:

• Provide leadership to the existing Quality Assurance team including managers and individual contributors.
• Assume primary responsibility for implementation and maintenance of all aspects of the company-wide quality management system. Determine and enforce (through functional groups) quality requirements in accordance with FDA QMSR and ISO standards.
• Lead preparation and planning for quality programs to support commercial activities and ongoing compliance, including complaint tracking, investigation, trending and reporting program.
• Direct quality program development with multiple functions (Operations, R&D, Sales & Marketing, external vendors) to assure adequate resources are available to meet project timelines.
• Organize and promote company-wide quality improvement efforts, including setting annual quality objectives.
• Hire, train, and manage QA Staff.
• Advise and consult with internal staff and scientific consultants who contribute to regulatory submissions, ensuring that appropriate information complies with regulatory regulations/standards/guidelines.
• Direct implementation and ongoing management of international complaint handling system; in compliance with FDA MDR and device vigilance reporting regulations.
• Act as or designate QA representative on product development teams (design control and risk management); critically review all documentation for submissions for consistency, accuracy and quality.
• Supervise and provide guidance on day-to-day quality activities including supplier quality/incoming inspection, management review, training, document control, non-conforming material, and corrective and preventive action.
• Supervise and manage internal audits and inspections including FDA, Cal FDB and others.
• Review Change Orders, Design Change Notices, etc., for compliance with FDA, and international regulations and standards.
• Monitor proposed changes in regulations, standards and guidance publications for impact on current and future development strategies.

Regulatory Affairs:

• Lead and develop a Regulatory Affairs team consisting of external and internal resources.
• Oversee the company’s regulatory filings including IDEs, supplements and amendments, Post marketing studies and reports, marketing submissions including De Novo and 510(k) and ongoing updates and annual/periodic reports for all company submissions.
• Organize and lead projects and subprojects related to RA strategies. May enlist external experts and other resources and manage related actions.
• Responsible for developing and maintaining regulatory affairs operating procedures and work instructions.
• Lead and/or oversee regulatory activities by reviewing study-related documents in accordance with applicable regulations.
• Work with external and internal resources for input and ideas for regulatory strategy to address FDA questions and planning for data framing to highlight Moximed technology advantages and context for risk.
• Act as or designate ‘Responsible Party’ for purposes of submitting information about Moximed’s applicable clinical trials (ACT) on in coordination with the Clinical Affairs department.
• Ensure the uniform and timely processing of Moximed Medical Device Reports (MDRs) in accordance with FDA regulations and internal operating procedures.
• Support product development/improvement projects with R&D and Engineering to assure applicable regulatory requirements are met.
• Provide regulatory strategy guidance to clinical and operations departments.
• Lead ad/promo review of product labeling, literature and company websites for accuracy, consistency and domestic and international regulatory compliance.
• Lead activities for State and Federal regulatory licenses, registrations and listings.
• Responsible for obtaining and maintaining FDA Small Business Designation.
• Support review of internal operating procedures and other controlled documents to ensure regulatory and quality compliance and consistency with regulatory commitments.
• Research, prepare and communicate new and changing product regulatory assessments and justifications.
• Assist with the training and development of personnel on Regulatory requirements.
• Support the Complaint Handling Unit, particularly with timely regulatory assessments of complaints for reportability determination for any adverse event or malfunction.

ABOUT YOU

• Bachelor’s or advanced degree preferred in Life Sciences, engineering or other technical discipline or other equivalent job experience.
• 15+ years of progressive experience in medical device quality assurance and/or regulatory affairs roles. Prior orthopedic medical device experience or experience with Class II/III implantable devices is a plus.
• Minimum of 12 years of progressive managerial experience successfully managing technical personnel and complex activities as required.
• Demonstrated strong leadership presence with ability to collaborate cross-functionally and build high-performing teams.
• Excellent working knowledge of FDA and international regulatory requirements and standards required. Experience with preparing international submissions/registrations required.
• Organize and lead teams and sub-teams to address complex quality and regulatory strategies in a growth-stage environment.
• Demonstrates strong organizational skills and the ability to collect and assess data, establish facts and report on findings.
• Demonstrates the highest levels of integrity, and good interpersonal and presentation skills.
• Have a working knowledge of ISO13485, 21 CFR820, preferred knowledge of MDR.
• Possess leadership qualities and be a great team player; possess the ability to communicate clearly and effectively, both orally and in writing; demonstrate capacity to calmly, clearly and consistently communicate regulations to technical functions within the company; possess the ability to handle multiple tasks, and the ability to think strategically while attending appropriately to details.
• Must be able to read, analyze, interpret and assist in the creation and refinement of company procedures; demonstrate the ability to define problems, collect data, establish facts, draw valid conclusions and report on findings. The candidate must be able to demonstrate the highest level of integrity, excellent negotiation skills, and excellent interpersonal and presentation skills.
• Strong work ethic.

At Moximed we believe that the unique contributions of all our team members create our success. To ensure that our culture continues to incorporate everyone’s perspectives and experience, we never discriminate based on race, religion, national origin, gender identity or expression, sexual orientation, age, marital, veteran, or disability status

Pay Transparency:

Moximed offers a comprehensive benefits package including competitive pay, health insurance, Disability Insurance, 401K, paid time off plus holidays, and a flexible approach to work schedules. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives.

California Pay Range: $160K-$220K

General Summary

As a member of the Manufacturing Engineering group at Penumbra, you will be called upon to solve complex problems and implement innovative solutions. You will provide manufacturing technology and robust solutions aimed at commercializing new products and continuously improving production processes. Working cross-functionally with engineering groups across the company, as well as with Production, Quality Control and Quality Assurance, you will resolve problems encountered on the production floor and throughout the business, and will apply your engineering knowledge and creativity to implement adaptations and modifications to the production line and to quality systems.

What You'll Work On

•Solve complex problems and implement innovative solutions

•Execute detailed root cause analysis and recommend vetted solutions

•Communicate and explain problems and solutions cross-functionally and inter-departmentally

•Collaborate closely with suppliers, ensure timely communication of updates, and respectfully request any necessary changes.

•Manage NCRs, deviations, engineering change orders, and supplier documentation while utilizing a Quality Management System to ensure continuous improvement and compliance.

•Engage in the troubleshooting of electromechanical products by employing failure analysis and problem-solving techniques, while also recommending and implementing effective solutions.

•Lead the implementation of projects at the supplier level, managing communications related to test plans, monitoring project timelines, and ensuring all milestones are met efficiently.

•Approach problems from a detail-oriented perspective

•Suggest independent recommendations for project approach, scope, and tactics

•Support production needs

•Create and maintain product and process documentation

•Monitor process and equipment performance and identify and implement process improvement activities to increase/optimize yield

•Design fixtures, acquire off-the-shelf tooling and equipment, and implement new fixturing on the production line

•Test processes, equipment, raw materials, and product

•Perform process validations

•Author protocols to execute tests and write reports and make conclusions and/or recommendations based on test results

•Plan, schedule, conduct, and coordinate detailed phases of engineering work as part of a project or as a total project

•Develop specifications of a product, process, or piece of equipment

•Develop, characterize, and optimize processes using statistical techniques and engineering knowledge and experience

•Coordinate with the appropriate suppliers and other external resources needed in developing and implementing process improvement plans

•Participate in project planning and scheduling

•Train assemblers, quality control and technicians, as necessary, on processes, equipment, and documentation

•Comply with quality system regulations, standards and procedures

* Indicates an essential function of the role

Location and Pay

•Alameda, CA

•$95,000 to $127,000

Position Qualifications

Minimum education and experience:

•Bachelor’s degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering or related degree with 2+ years relevant engineering experience, or an equivalent combination of education and experience

Additional qualifications:

•Engineering experience in a manufacturing environment recommended, medical device industry preferred

•Experience in troubleshooting and working with electromechanical devices

•Excellent written, verbal, and interpersonal communication skills required

•Knowledge of FDA regulations, Lean/Flow Manufacturing, and/or materials and manufacturing processes desired

•Proficiency in Word, Excel, PowerPoint, Access, and other computer applications required

•Supplier audits, risk management (FMEA, DFMEA, PFMEA), lean manufacturing/six sigma, equipment qualification

Working Conditions

•General office, laboratory, and clean room environments.

•Willingness and ability to work on site.

•Business travel from 0% - 10%

•Potential exposure to blood-borne pathogens.

•Requires some lifting and moving of up to 25 pounds.

•Must be able to move between buildings and floors.

•Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.

•Must be able to read, prepare emails, and produce documents and spreadsheets.

•Must be able to move within the office and access file cabinets or supplies, as needed.