Design Engineer

🔹 Now Hiring:
Design Engineer Supervisor (Medical Devices) 🔹

We’re 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 You’ll 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 – 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 We’re Looking For

• BS in Mechanical, Biomedical, Materials Engineering, or related field
• 5+ years of medical device product development experience
• Advanced proficiency in Solid Works 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