Are you passionate about continuous improvement, Lean manufacturing, and process optimization ? We're partnering with an innovative medical device manufacturer looking for a Senior Process Engineer to lead manufacturing improvements, process validation, and new product introductions.
What You'll Do
- Lead process improvement and Lean initiatives to improve quality, efficiency, and throughput.
- Develop and validate manufacturing processes (IQ/OQ/PQ).
- Conduct DOE, SPC, Gage R&R, and root cause analysis.
- Support new product launches and process transfers.
- Partner with Quality and Operations to drive CAPAs and continuous improvement.
- Mentor technicians and engineers while leading technical projects from concept to implementation.
What You Bring
- Bachelor's degree in Engineering
- 5+ years of medical device manufacturing experience
- Experience with IQ/OQ/PQ, ISO 13485, FDA 21 CFR Part 820
- Strong knowledge of DOE, SPC, PFMEA, and Lean Manufacturing
- Minitab experience (SOLIDWORKS is a plus)