JCW Group · 3 days ago
Principal Process Development Engineer
JCW Group is seeking a Principal 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 involves collaboration with R&D, Manufacturing, and Quality to establish scalable production processes and includes responsibilities from design to manufacturing transfer.
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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
Qualification
Required
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
Preferred
Catheter manufacturing experience
Electromechanical process exposure
Experience in small-to-mid-sized OEMs or CMOs