Philips · 2 days ago
Senior/Staff Project Engineer – Medical Device Mechanical Enclosures (San Diego, CA)
San Diego, CA
Full-time
Onsite
Senior Level, Lead/Staff
$110K/yr - $177K/yr
8+ years expPhilips is a health technology company dedicated to improving access to quality healthcare. The Senior/Staff Project Engineer will deliver high-impact design solutions for medical device components, ensuring compliance with regulatory standards and overseeing the mechanical development team.
B2BConsumer ElectronicsElectronicsLightingWellness
No H1B
U.S. Citizen Only
Responsibilities
Serve as the primary technical liaison for the outsourced mechanical development team and manage daily technical coordination, design reviews, and issue resolution. Ensure all external development efforts adhere to internal requirements, schedules, and quality standards
Create and maintain mechanical requirements for the device enclosure. Convert functional, regulatory, manufacturing, and usability needs into clear and actionable design inputs
Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and internal design control procedures. Support design reviews as well as verification and validation activities throughout the development process
Review mechanical designs, 3D models, drawings, and tolerance analyses to confirm compliance with requirements. Verify that the enclosure design supports PCBA integration, connectors, thermal management, EMI/ESD protection, ingress protection, and serviceability
Oversee and approve the release of mechanical BOMs, drawings, and specifications. Collaborate closely with contract manufacturing engineering teams to incorporate DFM/DFA feedback
Qualification
Required
8+ years of experience in medical device or other highly regulated product development, operating as an experienced individual contributor
Strong technical capabilities in mechanical design, including enclosure/assembly principles (EMI/EMC, thermal, IP), PCBA integration, CAD tools (SolidWorks, Creo), PLM systems, and medical-device safety standards (IEC 60601‑1)
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related discipline
Ability to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation
Excellent communication skills to convey technical requirements to internal and external partners
Experience collaborating with global manufacturing partners or contract manufacturers
Compliance with FDA 21 CFR Part 820, ISO 13485, and internal design control procedures
Ability to create and maintain mechanical requirements for the device enclosure
Review mechanical designs, 3D models, drawings, and tolerance analyses to confirm compliance with requirements
Oversee and approve the release of mechanical BOMs, drawings, and specifications
Manage daily technical coordination, design reviews, and issue resolution with the outsourced mechanical development team
Preferred
Master's degree in an engineering field
Experience in systems engineering
Experience in risk management
Experience in cross-disciplinary development
Bonus skills include requirements-management tools (DOORS, RequisitePRO)
Benefits
Generous PTO
401k (up to 7% match)
HSA (with company contribution)
Stock purchase plan
Education reimbursement
Company
Philips
Philips is a technology company that operates in various fields, including healthcare, consumer electronics, lighting, and home appliances.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$4.23BKey Investors
EXOR N.V.Bill & Melinda Gates FoundationInnovative Health Initiative
2025-03-19Post Ipo Equity
2024-05-23Post Ipo Debt· $756.82M
2023-11-07Grant· $44.6M
Leadership Team
Neil Mesher
CEO and SVP, UK and Ireland
Recent News
2026-01-22
2026-01-22
Company data provided by crunchbase