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Engineering Jobs in National City, CA
1 positions found
A
Design Engineer
β¦ New
Salary not disclosed
Now Hiring: Design Engineer Supervisor (Medical Devices)
Weβre seeking an experienced Design Engineer Supervisor to lead the design and development of innovative medical devices from concept through manufacturing. This role blends hands-on engineering with people leadership, regulatory oversight, and cross-functional collaboration in a highly regulated environment.
What Youβll Do
- Lead design and development activities through the full Design Control process
- Provide technical leadership across complex analyses including FEA, DFMA, FMEA, DOE, and fatigue analysis
- Ensure compliance with ISO 13485:2016 and FDA 21 CFR Part 820 (QMSR β effective Feb 2026)
- Oversee DHF, DMR, GD&T documentation, and design transfer to manufacturing
- Lead NCR, MRB, and root cause investigations to drive continuous improvement
- Use field reliability data and user feedback to enhance product performance, sterilization compatibility, and manufacturability
- Serve as the primary technical escalation point for engineering challenges
People & Project Leadership
- Coach, mentor, and develop a team of design engineers
- Assign work packages and manage project timelines and deliverables
- Conduct performance reviews and support hiring and onboarding of new talent
- Review and approve drawings, specifications, and validation protocols
What Weβre Looking For
- BS in Mechanical, Biomedical, Materials Engineering, or related field
- 5+ years of medical device product development experience
- Advanced proficiency in SolidWorks and mechanical CAD design
- Strong background in mechanical analysis, prototyping, and testing
- Hands-on experience across the full product development lifecycle
- Strong communication skills and a passion for solving complex technical problems
Nice to Have
- Experience with metals or reusable surgical instruments
- Plastic part and assembly design experience
- Experience working in a PDM environment
- Prior leadership or supervisory experience