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

Philips•San Diego, CA

7h•Onsite

About The Position

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. Serves as the primary technical liaison for the outsourced mechanical development team and manages daily technical coordination, design reviews, and issue resolution. Ensures all external development efforts adhere to internal requirements, schedules, and quality standards. Creates and maintains mechanical requirements for the device enclosure. Converts functional, regulatory, manufacturing, and usability needs into clear and actionable design inputs. Ensures compliance with FDA 21 CFR Part 820, ISO 13485, and internal design control procedures. Supports design reviews as well as verification and validation activities throughout the development process. Reviews mechanical designs, 3D models, drawings, and tolerance analyses to confirm compliance with requirements. Verifies that the enclosure design supports PCBA integration, connectors, thermal management, EMI/ESD protection, ingress protection, and serviceability. Oversees and approves the release of mechanical BOMs, drawings, and specifications. Collaborates 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.
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
Excel in communicating technical requirements to internal and external partners.

Nice To Haves

Master’s degree in an engineering field is preferred.
Experience in systems engineering, risk management, and cross‑disciplinary development.
Experience collaborating with global manufacturing partners or contract manufacturers.

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.