Senior/Staff Project Engineer – Medical Device Mechanical Enclosures (San Diego, CA)

Philips • San Diego, CA

2d • Onsite

About The Position

Senior/Staff Project Engineer – Medical Device Mechanical Enclosures (San Diego, CA) Delivers high‑impact design solutions for complex medical device components by translating advanced engineering requirements into compliant, high‑quality designs, resolving critical technical issues, and guiding rigorous validation to uphold Philips’ performance and regulatory standards. Your role: 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.

Requirements

• 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
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
• You excel in communicating technical requirements to internal and external partners and ideally bring experience collaborating with global manufacturing partners or contract manufacturers.
• US work authorization is a precondition of employment.
• For this position, you must reside in or within commuting distance to San Diego, CA.

Nice To Haves

• Master’s degree in an engineering field is preferred.
• Requirements‑management tools (DOORS, RequisitePRO) and experience in systems engineering, risk management, and cross‑disciplinary development.

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.

Benefits

• Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees