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

Philips•San Diego, CA

7h•$110,000 - $177,000•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. You're the right fit if: You bring 8+ years of experience in medical device or other highly regulated product development, operating as an experienced individual contributor. You possess 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). Bonus skills include requirements‑management tools (DOORS, RequisitePRO) and experience in systems engineering, risk management, and cross‑disciplinary development. You hold a Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related discipline; a Master’s degree in an engineering field is preferred. 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. How we work together: We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an office-based role. About Philips: We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business . Discover our rich and exciting history. Learn more about our purpose. Learn more about our culture. Philips Transparency Details: The pay range for this position in CA is $ $110,000 to $177,000. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. 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. Details about our benefits can be found here . At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information: US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to San Diego, CA. #LI-PH1 #LI-Office #ImageGuidedTherapy This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

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
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.
Experience collaborating with global manufacturing partners or contract manufacturers.
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.