Senior/staff Project Engineer – Medical Device Mechanical Enclosures (san Diego, Ca)
Philips
San Diego, CA, United States
$110,000 to $177,000 py
On-site
Medical device enclosure design
Fda 21 cfr part 820 compliance
Iso 13485 compliance
Deliver high-impact design solutions for complex medical device components by translating advanced engineering requirements into compliant, high-quality designs
Job Summary
Deliver high-impact design solutions for complex medical device components by translating advanced engineering requirements into compliant, high-quality designs.
Serve as the primary technical liaison for the outsourced mechanical development team and manage daily technical coordination, design reviews, and issue resolution.
Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and internal design control procedures, supporting design reviews and validation activities.
Matching Summary
Deliver high-impact design solutions for complex medical device components by translating advanced engineering requirements into compliant, high-quality designs.
Salary
$110,000 to $177,000
Skills & Requirements
Must-have
Medical device enclosure design
FDA 21 CFR Part 820 compliance
ISO 13485 compliance
SolidWorks or Creo CAD tools
Mechanical requirements creation
Outsourced development team liaison
Nice-to-have
Systems engineering experience
Risk management experience
Cross-disciplinary development experience
Global manufacturing partner collaboration
Key Requirements
8+ years of experience in medical device or regulated product development
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related discipline