Principal Process Development Engineer
Job in
Maple Grove, Hennepin County, Minnesota, 55311, USA
Listed on 2026-01-24
Listing for:
JCW Group
Full Time
position Listed on 2026-01-24
Job specializations:
-
Engineering
Manufacturing Engineer, Process Engineer, Quality Engineering, Validation Engineer -
Manufacturing / Production
Manufacturing Engineer, Quality Engineering, Validation Engineer
Job Description & How to Apply Below
Overview
We are seeking a Process Development Engineer to support early-stage product development and drive the transition of new medical device designs into validated, manufacturing-ready processes. This role works closely with R&D, Manufacturing, and Quality to establish scalable, high-yield production processes.
Responsibilities- Partner with R&D to translate design requirements into repeatable manufacturing processes
- Develop and mature processes from early development through pilot line and manufacturing transfer
- Design and specify production equipment, tooling, and fixtures
- Lead process characterization and yield improvement efforts
- Develop PFMEAs, process control strategies, and validation protocols
- Execute process validation activities (IQ/OQ/PQ)
- Train operators and support pilot line operations
- Own processes through stabilization and formal handoff to Manufacturing
- Bachelor’s degree in Engineering (Mechanical, Biomedical, Manufacturing, or related)
- 5+ years of Process Development experience in medical devices
- Demonstrated experience bringing products from R&D into commercial manufacturing
- Strong understanding of design controls and validation requirements
- Hands-on experience with process characterization and optimization
- Electromechanical process exposure
- Experience in small-to-mid-sized OEMs or CMOs
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