Assistant Project Manager

Supports cross-functional medical device development projects from planning through design control, validation, manufacturing transfer, and product launch.

Job Requirements

• Bachelor’s degree in engineering or a related technical discipline

• Minimum of 3 years of project management experience within the medical device industry

• Experience supporting regulated medical device product-development projects

• Experience coordinating cross-functional activities across engineering, quality, regulatory, manufacturing, and operations

• Experience developing and maintaining project plans, schedules, status reports, and presentations

• Experience tracking project timelines, budgets, deliverables, risks, and action items

• Experience supporting medical device design-control and change-management processes

• Working knowledge of Microsoft Project

• Experience coordinating suppliers, external development partners, or contract manufacturers

• Experience maintaining project documentation and decision records

Preferred Skills

• Master’s degree in engineering or a related technical discipline

• 3–5 years of overall medical device industry experience

• Experience with single-use medical devices, endoscopes, peripheral equipment, or surgical systems

• Experience with endoscopy systems

• Experience with digital image-processing systems

• Systems engineering experience

• Experience supporting medical product manufacturing transfers

• Experience coordinating IQ, OQ, and PQ validation activities

• Experience developing or maintaining device master records

• Experience with work instructions, product specifications, PFMEAs, manufacturing validation plans, and transfer documentation

• Experience working within a formal Stage-Gate product-development process

• Knowledge of FDA Quality System Regulation requirements

• Knowledge of ISO 13485 and EU Medical Device Regulation requirements

• Knowledge of ISO 14971 medical device risk-management requirements

• Knowledge of IEC 60601, IEC 60825, and IEC 62366 standards

Job Responsibilities

• Support planning and execution of cross-functional medical device development projects

• Develop and maintain project plans, schedules, milestones, and deliverable trackers

• Prepare project status reports, presentations, and leadership review materials

• Coordinate activities across engineering, regulatory, quality, manufacturing, operations, suppliers, and contract manufacturers

• Monitor project progress against approved timelines, budgets, and technical deliverables

• Track project costs, forecasts, commitments, and actual spending

• Identify project risks, dependencies, resource constraints, and schedule issues

• Support development and tracking of mitigation and contingency plans

• Document project decisions, meeting outcomes, action items, and assigned responsibilities

• Monitor completion of project tasks and escalate overdue or blocked activities

• Support medical device design-control documentation and product-development processes

• Coordinate engineering change and document-control activities

• Support product risk-management activities and required regulatory documentation

• Maintain project records in accordance with applicable quality-system requirements

• Support Stage-Gate reviews and product-development approval activities

• Coordinate manufacturing transfer activities for medical products

• Track completion of IQ, OQ, and PQ validation requirements

• Support development and transfer of device master records, work instructions, product specifications, PFMEAs, and validation documentation

• Coordinate production-readiness, process-validation, and manufacturing handoff activities

• Support corrective actions related to schedule, budget, quality, and project performance

• Coordinate project activities with external suppliers and contract development or manufacturing organizations

• Maintain project dashboards, schedules, reports, and supporting documentation

Pay: 110k-120k/year

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

Pay Details: $110,000.00 to $120,000.00 per year

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

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