Engineering Project Manager, Sustaining (Medical Devices)

Location: Onsite in Irvine, California, United States

Salary: $106,000–$140,000 per year, plus eligibility for up to a 10% annual bonus.

Company

Medical device engineering organization supporting commercially released products throughout their product lifecycle.

What you will do

• Lead complex sustaining engineering and product lifecycle projects from initiation through implementation.
• Manage project scope, priorities, schedules, resources, risks, dependencies, and deliverables across multiple concurrent initiatives.
• Coordinate engineering and design changes, component obsolescence, supplier qualification, alternate sourcing, and supply continuity projects.
• Lead manufacturing transfer, localization, production readiness, cost reduction, and product or process improvement initiatives.
• Coordinate activities supporting CAPA, complaints, reliability, risk management, and product quality improvements.
• Provide executive-level reporting and ensure compliance with quality procedures, Design Controls, change control, and regulatory standards.

Requirements

• 3–5+ years of project or program management experience in medical devices, life sciences, or another regulated industry.
• Experience with sustaining engineering and product lifecycle activities, including design changes, manufacturing transfer, supplier qualification, component obsolescence, or supply continuity.
• Strong project planning, risk management, problem-solving, stakeholder management, negotiation, and executive communication skills.
• Ability to influence without direct authority, facilitate cross-functional decisions, and manage shifting priorities.
• Working knowledge of project or product lifecycle tools such as MS Project, Smartsheet, Jira, Agile PLM, or Windchill.
• Effective written and spoken English and the ability to interpret technical documents, schematics, and written instructions.

Nice to have

• PMP or another recognized project management certification.
• Experience with Class II medical devices in an FDA-regulated environment.
• Knowledge of medical device Design Controls, CAPA, risk management, change control, supplier qualification, manufacturing transfer, and quality system requirements.
• Bachelor’s degree in engineering or a related technical discipline, or equivalent relevant experience.

Culture & Benefits

• Work in a laboratory environment with regular interaction across Engineering, Quality, Regulatory, Operations, Manufacturing, Supply Chain, and Product Management.
• Medical, dental, vision, life, disability, and flexible spending benefits.
• 401(k), vacation, sick leave, holidays, and paid maternity leave.
• Access to an onsite wellness clinic, fitness center, café, and employee assistance program.
• Additional voluntary accident, critical illness, hospital, long-term care, and pet insurance options.