Related skills
fmea npi iso 13485 dfm dfa📋 Description
- Execute design transfer from NPI through EVT/DVT, pilot builds, ramp-up.
- Develop and maintain design transfer docs: drawings, specs, BOMs.
- Support production readiness reviews by identifying design risks and gaps.
- Partner with Product Engineering for manufacturing input into design decisions.
- Serve as technical interface with Contract Manufacturers during design transfer.
- Analyze early manufacturing data to identify design risks.
🎯 Requirements
- Bachelor's or Master's in Mechanical, Industrial, or Biomedical Engineering.
- 5+ years in regulated manufacturing; design transfer exposure.
- Hands-on EVT/DVT builds, pilot runs, and ramp-ups.
- Familiarity with ISO 13485 and FDA 21 CFR 820.
- Experience with DFM and DFA.
- Ability to influence cross-functional teams without authority.
🎁 Benefits
- Fast-paced environment with room for creativity.
- Work with a talented team to impact healthcare.
- Flexible hours remotely with unlimited vacation.
- Health and well-being program with digital therapy.
- Remote or Hybrid work policy.
- Tech stack insights via our StackShare link.
Meet JobCopilot: Your Personal AI Job Hunter
Automatically Apply to Engineering Jobs. Just set your
preferences and Job Copilot will do the rest — finding, filtering, and applying while you focus on what matters.
Help us maintain the quality of jobs posted on Empllo!
Is this position not a remote job?
Let us know!