Jobs in San Ysidro, CA

Litigation Secretary

Location: San Diego, CA

Pay Rate and Benefits: $90,000 to $120,000 per year, along with comprehensive benefits such as medical, dental, vision, etc.

Position Type: Full-time, Hybrid, Direct Hire

LHH is currently seeking a skilled Litigation Secretary to join a large firm in their San Diego, CA. As a Civil Litigation Secretary, you will play a crucial role in supporting our legal team in handling civil litigation matters. This position requires excellent organizational skills, a strong attention to detail, and the ability to work in a fast-paced environment.

Responsibilities:

• Provide comprehensive administrative support to attorneys and legal professionals in civil litigation matters.
• Prepare, proofread, and format legal documents, including pleadings, motions, briefs, and correspondence.
• Maintain and organize case files, documents, and records.
• Manage court deadlines and assist in calculating pre-trial dates.
• Coordinate and schedule meetings, depositions, and court appearances.
• Conduct legal research and gather relevant information from various sources.
• Assist with court filings, including e-filing in state and federal courts.
• Prepare and handle document production and discovery requests.
• Assist with trial preparation, including organizing exhibits and trial binders.

Qualifications:

• 3+ years of prior experience as a civil litigation secretary, supporting litigators in civil defense.
• Strong knowledge of civil litigation procedures and insurance defense work.
• Proficiency in court deadlines and calculating pre-trial dates accurately.
• Experience with court filings, including e-filing in state and federal courts.
• Advanced skills in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Excellent organizational skills and the ability to manage multiple tasks efficiently.
• Strong attention to detail and accuracy in document preparation.
• Effective written and verbal communication skills.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act

• Los Angeles City Fair Chance Ordinance

• Los Angeles County Fair Chance Ordinance for Employers

• San Francisco Fair Chance Ordinance

Title: Senior Employment Attorney – Hybrid (San Diego, CA)

Location: Hybrid (San Diego, CA) – Downtown Office & Flexible Remote Days

About the firm:

Our client is a nationally recognized plaintiff-side employment and consumer rights law firm committed to advancing justice for employees who have faced discrimination, retaliation, wrongful termination, wage theft, harassment, and other workplace violations.

They are seeking a Hybrid Employment Attorney to join their San Diego office. The ideal candidate will be a motivated, skilled advocate with a strong commitment to representing employees and improving workplace rights.

Key Responsibilities:

• Handle a caseload of plaintiff-side employment law matters, including discrimination, retaliation, wrongful termination, harassment, wage and hour claims, and related employment disputes.
• Draft complaints, motions, discovery responses, briefs, and other litigation documents.
• Conduct legal research, case analysis, and client interviews.
• Take and defend depositions, attend court hearings, mediations, and settlement negotiations.
• Supervise and collaborate with paralegals and support staff.
• Provide compassionate, trauma-informed counsel and representation.
• Maintain strong communication with clients and opposing counsel.

Qualifications:

• J.D. from an accredited law school and active membership in the California State Bar.
• 3+ years of litigation experience, preferably in employment law or related civil rights areas.

Salary and Other Compensation:

The annual salary for this position is between [$180,000 – $200,000 annually]. Factors which may affect pay within this range may include geography/market, skills, education, experience and other qualifications of the successful candidate.

Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: [medical insurance] [dental insurance] [vision insurance] [401(k) retirement plan] [life insurance] [long-term disability insurance] [short-term disability insurance] [2 to 3 weeks of paid time off]

Trusts & Estates Paralegal

Location: San Diego, CA

Salary Range and Benefits: $90,000 to $115,000 per year, along with comprehensive benefits such as medical, dental, vision, etc.

Position Type: Full-time, Hybrid (1-2 Days Onsite), Direct Hire

LHH is partnering with a prestigious law firm specializing in high-wealth, high-profile trusts & estates and probate matters, in seeking an experienced and empathetic Trusts & Estates Paralegal. The ideal candidate should have a minimum of 3 years' experience in trust & estate law and possess exceptional organizational and interpersonal skills. As a Trusts & Estates Paralegal you will play a crucial role in servicing our high-wealth, high-profile clients. Your responsibilities will include:

Responsibilities:

• Client Interaction: Meet with clients, trustees, family members, and communicate with beneficiaries to provide support and guidance.
• Tax Compliance: Prepare estate and gift tax returns to ensure compliance with relevant tax laws.
• Document Preparation: Draft and prepare a variety of legal documents, including deeds, asset spreadsheets, probate pleadings, and fiduciary accountings.
• Estate Administration: Assist in the administration of probate estates and trusts, including asset allocation, asset transfers, and the sale of assets.
• Legal Support: Draft trusts, wills, and related documents as needed to support our clients' needs.
• Financial Coordination: Work closely with financial institutions, accountants, and appraisers to collect estate assets and financial information.
• Guardianship and Conservatorship: Prepare and file petitions, accountings, and reports related to guardianship and conservatorship proceedings.
• General Support: Perform other duties as assigned by attorneys to support our clients effectively.

Qualifications:

• Experience: Minimum of three years' experience as a trust & estates paralegal.
• Education: Paralegal certificate.
• Detail-Oriented: Strong attention to detail, proactive, dependable, and highly organized.
• Technical Skills: Excellent math and computer skills, including proficiency with legal software.
• Analytical Skills: Strong problem-solving and analytical skills.
• Communication: Clear and concise communication skills, both written and verbal.
• Legal Knowledge: Familiarity with probate processes, rules, and judicial council forms.
• Location: Ability to work in the Los Angeles office four times a week.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act

• Los Angeles City Fair Chance Ordinance

• Los Angeles County Fair Chance Ordinance for Employers

• San Francisco Fair Chance Ordinance

Insight Global is seeking an experienced EPLAN Electrical Designer to support the development of its large-scale metal additive manufacturing platform, the Advanced Test Demonstrator (ATD).

In this role, you will play a critical part in electrical documentation, panel fabrication support, and system integration activities for a complex LPBF (laser powder bed fusion) 3D printer environment. This includes creating and updating EPLAN schematics, supporting hands-on panel builds, documenting wiring and fluid routing, and collaborating with cross-functional engineering teams (controls, mechanical, and R&D).

The ideal candidate is highly experienced in mixed-voltage electrical systems, industrial standards, and shop-floor integration. This is a hands-on role requiring strong troubleshooting, fabrication support, and comfort working around high-power distribution and sensitive signal environments. While not required, experience with LabVIEW OOP and industrial additive manufacturing systems is highly advantageous.

Qualifications

Required Skills & Experience

• 10+ years of electrical design experience
• Proficiency with EPLAN Electric P8 for electrical schematics, wiring diagrams, harness documentation, and connector pinouts
• Experience supporting panel fabrication and providing real-time troubleshooting for mixed-voltage enclosures
• Experience updating as-built documentation from shop-floor redlines
• Strong knowledge of industrial electrical standards (UL, CE, NEC, NFPA)
• Strong wiring, layout, and enclosure integration skills for R&D or industrial machine environments

Nice to Have Skills & Experience

• Experience with EPLAN Fluid for documenting chiller loops, pneumatics, and gas routing
• LabVIEW OOP experience
• Background in additive manufacturing, large industrial printers, or automation equipment
• Familiarity with pneumatic manifolds, argon systems, or fluid-cooled industrial machinery
• Experience coordinating electrical requirements within CAD enclosure models
• Comfortable working on shop floors with high-power distribution and sensitive signal routing

KIC is looking for a hands-on Production Assembly Technician to join our manufacturing team in Rancho Bernardo. In this role you will build and assemble components such as probes, shields, cable assemblies, and wiring bundles used in electronics manufacturing equipment.

This is an active production role that involves working with wiring, small electrical assemblies, and moving between workstations throughout the day. Candidates who enjoy hands-on manufacturing work and building physical products as part of a team will thrive in this environment.

What You’ll Do

A typical day may include:

• Assembling probes, shields, cable assemblies, and wiring bundles used in KIC products

• Cutting, stripping, routing, and bundling wires for production assemblies

• Following detailed work instructions and production work orders

• Moving between assembly stations to support different stages of the production process

• Performing visual inspections to ensure assemblies meet quality standards

• Occasionally assisting with packaging or preparing finished assemblies

This role focuses primarily on product assembly and manufacturing, not warehouse picking or distribution work.

Work Environment

This is a hands-on manufacturing role that includes:

• Building cable assemblies, probes, and wiring bundles

• Using hand tools such as wire strippers, cutters, and crimpers

• Moving between work areas and being physically active throughout the day

• Repetitive assembly tasks requiring attention to detail

• Occasional lifting of materials up to 40 lbs

Qualifications

• High school diploma or GED preferred

• Experience in manufacturing, electronics assembly, or production environments is a plus

• Ability to work with small hand tools and follow assembly instructions

• Strong attention to detail and consistent quality standards

Compensation & Benefits

Hourly Pay: $18–$20 per hour (DOE) + Profit Share Bonus Program

Benefits include:

• Fully paid medical, dental, and vision insurance

• 401(k) with company match (up to 4%)

• Flexible Spending Account (FSA)

• Paid Time Off and paid holidays

• Annual benefit allowance of $3,600 (paid bi-weekly)

• Supplemental short-term and long-term disability insurance

Why Join KIC

At KIC, we design and build thermal measurement tools used by electronics manufacturers around the world. The work we do in our facility directly supports customers who rely on our technology to improve their manufacturing processes.

You’ll be part of a team that builds products supporting the technology people rely on every day.

Apply here:

LHH Technology is seeking an experienced Workday Systems Analyst to join our client's team in a full-time role located in sunny San Diego, CA.

This role requires an experienced Workday Business Analyst with a strong finance and accounting background to support, configure, and optimize Workday Financials. The position focuses on understanding and maintaining the end‑to‑end Workday finance and accounting setup, including Financial Accounting, Accounts Payable and Receivable, Banking, Procurement, and Projects. Responsibilities include performing Workday administrative functions such as business process, tenant, and security configuration; monitoring and troubleshooting integrations and finance-related business processes; leading Workday release planning and impact analysis; and coordinating configuration, testing, and deployment activities. The role partners closely with finance and accounting stakeholders to gather and document requirements, maintain design workbooks, recommend process improvements, and ensure scalable, low‑customization solutions aligned with organizational standards. Additional responsibilities include designing and testing simple integrations using Workday tools, supporting data conversion efforts, owning cutover activities for go‑lives, building regression and acceptance test scenarios, and creating and maintaining standard and ad‑hoc reports and dashboards to support business needs.

Salary & Benefits:

• Salary Range: $80k to $110k
• Retirement Plan with Employer Match
• Paid Time Off, Extended Sick Leave and Paid Holidays
• Medical/Dental/Vision/FSA/Life Insurance
• Employee Discounts and Wellness Programs

Qualifications:

• Required: 3+ years of experience as a Business Analyst working on Workday ERP Elevation, Integrations or Implementations. Key Workday module experience with: Financial Accounting, Accounts Receivable, Accounts Payable, Banking, Procurement and Projects.
• Required: 2+ years of experience as an accountant or financial professional prior to specializing in Workday ERP software as a Functional (not technical) professional.
• An Accounting Degree would substitute for experience working as an accounting professional in accounting.
• Required: Experience performing Workday administrative functions including business process and tenant configuration. Monitor and troubleshoot integrations and BPs supporting finance processes, determine root cause, and implement solutions.
• Very Nice To Have: Experience with security and how to best leverage Workday to automate processes.
• Very Nice To Have: Experience building regression and acceptance test scenarios working closely with business process owners.
• Very Nice To Have: Experience evaluating, communicating, and coordinating the technical impacts of Workday configuration decisions.
• Very Nice To Have: Experience Design, configure, and test simple integrations between Workday and external systems using Enterprise Integration Builder (EIB) and other Workday tools. Support data conversion efforts for acquisitions as needed.
• Very Nice To Have: Experience architecting system configuration, leading testing, and implementation.
• Very Nice To Have: Ability to work through complex issues and challenges and present business stakeholders with clear options for solutioning.

Responsibilities:

• Monitor the system for problems and identify and implement corrective and preventive measures.
• Understand the overall finance/accounting setup of Workday, including overall functional usage of Workday.
• Perform Workday administrative functions including business process and tenant configuration. Monitor and troubleshoot integrations and BPs supporting finance processes, determine root cause, and implement solutions.
• Understand Workday security including adjusting domains and security groups. Maintain the roles (for all business functional areas) related to security groups; this includes working with functional areas to assign and change roles depending on job function.
• Lead the Workday release preparation, including monitoring Workday Community for new release functionality. Coordinating with impacted business units to make required configuration/ content / reporting / integration changes.
• Analyze and manage Workday releases, assess impacts including architecting, configuring, prototyping, testing, and deploying updates.
• Leverage business knowledge and expertise to identify and recommend opportunities for process improvements, advise stakeholders on options, risks, and any impacts on other processes or systems.
• Coordinate with finance and accounting team to understand and document business requirements and use cases, design, and configure Workday. Maintain design workbooks.
• Ensure that recommendations from implementation partner fit Sees standards of minimum customization, maximum scalability.
• Evaluate, communicate, and coordinate the technical impacts of Workday configuration decisions.
• Build regression and acceptance test scenarios working closely with business process owners.
• Responsible for owning and updating the cutover activities for project go live.
• Design, configure, and test simple integrations between Workday and external systems using Enterprise Integration Builder (EIB) and other Workday tools. Support data conversion efforts for acquisitions as needed.
• Report Writer & Owner: Create, maintain, and process standard and custom ad-hoc reports and dashboards, to meet business needs.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act

• Los Angeles City Fair Chance Ordinance

• Los Angeles County Fair Chance Ordinance for Employers

• San Francisco Fair Chance Ordinance

Job Title: QA Consultant (GxP)

Location: San Diego, CA (On-site)

Position Type: Contract / Consultant

Department: Quality Assurance

Reports To: Site Quality Head / Director, QA

Hours requirement: 8 to 5; may need to have some flexibility to work earlier/late as needed

About Us

Based in San Diego, our site operates as a clinical-stage biopharmaceutical facility utilizing unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure. We are passionate about making an impact on patients' lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases. Our goal is to deliver potential single-treatment cures for patients in need.

Position Summary

The Quality organization is seeking an experienced QA Consultant (GxP) to join our team in San Diego, CA. In this on-site contracted role, you will lead the enhancement and maintenance of local Quality Systems, with a primary focus on the Quality Management System (QMS), Electronic Data Management System (EDMS), Document Control, and overall Quality Assurance functions.

You will ensure compliance with regulatory requirements while supporting site-specific needs. This role is integral to the overall GxP Quality system, including processes such as Change Control, Deviation, CAPA, Training, and Document Control, as well as tracking and reporting Quality System Metrics. You will collaborate closely with cross-functional GxP partners including QA, QC, Manufacturing, Validation, Supply Chain, Facilities, and Clinical teams.

Key Responsibilities

Support concurrent activities for legacy Quality systems during QMS integration and system migration phases.

Provide QA oversight for approximately 125 updated SOPs and manual/paper-based systems.

Monitor quality metrics and dashboards to reduce overdue records and maintain effective QMS controls.

Operate and support legacy Quality systems during the transition to new platforms.

Oversee and execute Document Control activities for GxP documents, including manufacturing, clinical, and product quality records.

Assist in managing the GxP Training Program and deliver training on Quality System topics (e.g., Annual GMP Training, Change Control, Deviation, CAPA).

Collaborate with Change Control, Deviation, MRB, and CAPA owners to ensure timely completion and compliance of quality records.

Perform operational functions within the ComplianceWire Learning Management System (LMS) and Qualio (EDMS).

Support continuous improvement efforts for events within EDMS and LMS.

Work with document owners to ensure timely periodic review of procedures.

Assist in the creation and revision of SOPs, policies, forms, templates, and reporting tools.

Generate and trend quality metrics, communicating findings to leadership.

Support internal and external audits, including regulatory agency or partner audits, and assist in executing corrective action plans.

Review and approve paper-based quality documentation and electronic quality records.

Promote a culture of quality, teamwork, and accountability with a patient-first mindset.

Align daily activities with department goals and company values.

Ability to lift up to 20 pounds as needed.

Qualifications

Education: Bachelor’s degree in Life Sciences or related discipline (an equivalent combination of education and experience may be considered).

Experience: Minimum of 8 years of experience in a GxP environment (pharmaceutical, biotech, or cell/gene therapy manufacturing preferred).

Technical Skills:

Strong knowledge of Quality Management Systems in a cGxP manufacturing environment.

Proficiency in core Quality systems: Change Control, Deviations, CAPA, Document Control, and Training.

Hands-on experience with Electronic Document Management Systems (EDMS) and Learning Management Systems (LMS) such as ComplianceWire or Qualio.

Advanced proficiency in Microsoft Office Suite (Excel, PowerPoint, Word).

Competencies:

Exceptional written and verbal communication skills.

Strong attention to detail and ability to manage multiple projects simultaneously.

Proven ability to work independently and collaboratively in a fast-paced, dynamic environment.

Experience developing training materials and delivering training to employees.

Demonstrated ability to write and revise SOPs, work instructions, and Quality System documents.

Company Description

Proprioceptive Solutions, LLC is a multidisciplinary network of healthcare and performance specialists revolutionizing whole-person healthcare and human performance. With an evidence-based approach, the team focuses on comprehensive solutions for neuromusculoskeletal pathologies and corrective performance training. By utilizing periodized treatment models rather than linear methods, the organization achieves improved patient outcomes, often exceeding 25-50% over traditional practices. Located in San Diego, California, Proprioceptive Solutions is committed to advancing both patient care and the broader healthcare economy by fostering innovation and creating opportunities in health sciences and kinesiology.

Role Description

This part-time, on-site Doctor of Physical Therapy role is based in San Diego, CA. The primary responsibilities include evaluating and treating patients with neuromusculoskeletal conditions, creating individualized rehabilitation plans, and providing patient-centered care. The role also involves collaborating with a multidisciplinary team to deliver evidence-based treatments and optimizing human movement and functionality through tailored therapeutic interventions.

Qualifications

• Expertise in Physical Therapy, Patient Care, and Rehabilitation techniques
• Proficiency in addressing Orthopedics and Medicine-related issues
• Strong understanding of neuromusculoskeletal conditions and evidence-based treatment practices
• Exceptional communication and interpersonal skills to collaborate within a multidisciplinary team
• Doctor of Physical Therapy (DPT) degree and current licensure to practice in California
• Commitment to delivering high-quality, patient-focused care
• Experience with periodized rehabilitation models is an asset

Prototype Engineering Technician

Pay: $25.00-$29.00/hour

Location: San Diego, CA (Onsite)

Duration: 12-Month Contract

Schedule: Standard Working Hours

Job Responsibilities

In this role, you will support prototyping activities within a collaborative manufacturing environment. The position works closely with engineering teams to assist with product development initiatives and the fabrication of prototype components.

Key responsibilities include:

• Supporting prototype builds in collaboration with Product Development Engineering.
• Assisting with fixture setup, fabrication, and prototype assembly.
• Producing components using machining, rapid prototyping, and fabrication equipment.
• Creating and modifying 3D models using CAD software to support prototype development.
• Supporting cross-functional teams in engineering and manufacturing activities related to product prototyping.

Essential Duties and Job Functions

• Work with engineers to set up and fabricate prototype fixtures and components.
• Operate traditional and CNC machine shop equipment including mills and lathes.
• Produce prototype parts using rapid prototyping equipment such as:
• 3D printers
• Laser cutters
• Other fabrication tools
• Interpret engineering drawings, prints, and schematics to fabricate parts accurately.
• Perform fabrication and assembly of mechanical, electronic, and electro-mechanical components.
• Utilize CAD software (e.g., SolidWorks) to design or modify solid models for manufacturing.
• Use measurement tools such as calipers, micrometers, and height gauges to verify dimensions.
• Follow established machine shop policies, procedures, and safety standards.
• Maintain compliance with safety protocols, including the use of proper PPE.
• Utilize common hand and power tools during prototype fabrication and assembly.

Knowledge & Skills

• Strong mechanical aptitude and troubleshooting abilities.
• Basic mechanical fixture and/or electro-mechanical design experience.
• Ability to read and interpret technical drawings and schematics.
• Familiarity with machine shop environments and equipment.
• Experience with measurement and inspection tools.
• Ability to work effectively in a fast-paced and dynamic environment.
• Experience with rapid prototyping equipment such as 3D printers and laser cutters.
• Proficiency with Microsoft Office applications.
• Strong attention to detail and commitment to safety practices.

Education & Experience

Required:

• 1-3 years of machine shop experience using traditional equipment such as:
• Conventional lathes
• Mills
• CNC milling machines
• Experience with fabrication and assembly of mechanical or electro-mechanical components.
• Experience using hand tools and power tools in a manufacturing environment.

Preferred / Nice to Have:

• Associate's degree or relevant technical training.
• Experience maintaining tools and managing material inventory.
• Familiarity with optical measurement equipment (e.g., Keyence systems).
• Industry certification or trade school training in a related field.
• Knowledge of 3D CAD software (SolidWorks and/or Fusion 360 preferred).
• Ability to lift up to 30 lbs.
• Willingness to take on additional responsibilities and assignments as needed.

Immediate need for a talented R&D Project Manager. This is a 12+ months contract opportunity with long-term potential and is located in San Diego, CA(Hybrid). Please review the job description below and contact me ASAP if you are interested.

Job ID:26-08555

Pay Range: $60 - $90/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Lead and manage multiple R&D programs and/or large-scale product development projects, from feasibility through commercialization, including Class II and/or Class III medical devices (with emphasis on electrically active/medical electrical equipment where applicable).
• Develop and maintain integrated program plans, timelines (Gantt charts), budgets, resource plans, and risk registers; proactively identify and mitigate risks across technical, regulatory, clinical, commercial, and electrical safety dimensions.
• Define project scope, objectives, deliverables, and success criteria; create and maintain project charters, work breakdown structures (WBS), and detailed schedules.
• Lead cross-functional core teams (R&D/Engineering, Quality, Regulatory Affairs, Clinical, Manufacturing, Marketing, and Operations) to execute program objectives; facilitate effective decision-making and resolve conflicts.
• Drive adherence to Design Control processes (21 CFR 820.30), risk management (ISO 14971), usability engineering (IEC 62366), basic safety and essential performance requirements for medical electrical equipment (IEC 60601-1 series), and other applicable standards throughout the product lifecycle.
• Provide regular status updates, executive-level reporting, and dashboards to senior leadership and stakeholders; communicate program progress, issues, decisions, and changes clearly and proactively.
• Support regulatory strategy development and submissions (e.g., 510(k), PMA, technical files for CE marking), including coordination of electrical safety testing, EMC compliance (IEC 60601-1-2), and collateral/particular standards as needed.
• Foster a collaborative, innovative, and compliant culture within program teams.
• Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and cross functional teams management.
• Lead cross-functional teams through identification of risks & mitigations, problem resolution and root cause analysis, corrective and preventive action.
• Develop and maintain integrated project plan with risk-based timeline, critical path milestones, resource allocation, roadmap with clear milestones for gap analysis, risk management, remediation, testing, certification and budget tracking to support certification goals
• Monitor the effectiveness and performance of the launch and project team and facilitate the development of contingency plans, recommending corrective actions as required.
• Ensure compliance with quality management systems and regulatory requirements, where applicable.
• Lead the team to prepare for and execute Phase Gate. Represent the team with Client leaders, ensuring such decisions are informed by a balanced and clearly articulated representation of the relevant data.
• Leverage technical acumen to partner with engineering teams, monitor development progress, and ensure alignment between technical deliverables and program timelines
• Drive design control discipline throughout product development, ensuring compliance
• Conduct or oversee gap assessments against general, collateral, and particular standards for medical electrical equipment safety and essential performance.
• Manage integrated risk management (per ISO 14971), including essential performance definition, hazard analysis, risk controls, and verification.
• Coordinate and manager the execution of test plans for electrical safety, EMC, mechanical, environmental, and essential performance requirements; coordinate pre-compliance and formal third-party testing.
• Oversee compliance documentation: technical files, risk management files, test reports, essential performance rationale, and certification justification.
• Integrate compliance activities with the quality management system (ISO 13485) and other regulatory requirements (FDA, EU MDR, etc.).
• Serve as primary liaison with notified bodies, test labs, and regulatory consultants to support certification and post-compliance needs.
• Drive a safety-focused culture while ensuring the team meets the September 2027 compliance target

Key Requirements and Technology Experience:

• Key Skills;Bachelor’s degree in Engineering (Biomedical, Electrical, Mechanical, or related),Life Sciences, or equivalent.
• 3-5 years of project management in medical devices, with ≥5 years leading compliance programs for medical electrical equipment.
• Proven track record of successfully delivering medical device programs from concept to market launch (including regulatory clearance/approval).
• Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971 risk management, IEC 62304 (software), and global regulatory pathways (510(k), De Novo, PMA, MDR).
• Proficiency with project management tools (e.g., MS Project, Jira, Smartsheet, or similar) and standard office software.
• Project Management Professional (PMP) certification not required but is preferred
• Scrum Master and SAFE Agile certification is preferred.
• Experience in medical device industries required, including experience in FDA or other regulated environments.
• Knowledge of the medical device industries beneficial integrating science and technology into business processes.
• Technical background in electrical, mechanical, or biomedical engineering
• Expert in the development and deployment of program management tools and techniques including methods for tracking progress, risk management and delivery of major milestones.
• Understanding of engineering development lifecycles and the ability to translate technical inputs into program-level actions and timelines
• Excellent influencing skills with the ability to achieve challenging goals through others without direct authority across different functions, external partners, geographies, and cultures.
• Drive for accountability within self and others.
• Proven project management experience with delivering medium-to large-scale projects in managed service model from concept through delivery and operations
• Relentless advocacy for the customer with a focus on meeting or exceeding customer requirements.
• Driving the team to make trade-offs that optimize customer and business value while maintaining program velocity and outcomes that sustain the highest standards of quality.
• Direct experience with major test labs and certification bodies for medical electrical equipment standards.
• Experience with programmable electrical medical systems (PEMS) or software-inclusive devices (IEC 62304 knowledge a plus)
• Proven success taking Class II (or higher) active medical electrical devices from gap assessment through third-party certification.
• Strong knowledge of ISO 14971, ISO 13485, general/collateral/particular standards for medical electrical safety and essential performance, and EMC requirements.
• Familiarity with FDA QSR (21 CFR Part 820), EU MDR/IVDR, or other global regulations.

Our client is a leading Pharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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