Production Engineer – Project Engineer (1)
Core
Hands-on manufacturing engineering role implementing product and process changes for medical devices used in ultrasound, surgical visualization, and image-guided procedures.
Role type
Senior IC production/project engineer (medical devices)
Builds
Medical device scanner/system assemblies, mechanical/electronic assemblies, and validated manufacturing processes
Domain
Medical device manufacturing / Quality Systems / Process Validation
Required skills
ECO/NPI implementation, NC/INV/CAPA management, Equipment Qualification, Process Validation, Root Cause Analysis, Risk Management, GMP compliance, Manufacturing process controls
Preferred skills
Medical device manufacturing experience, Project execution, Analytical problem-solving, Documentation discipline
Technologies
TrackWise, pFMEA, Control Plans, SOP/WI
Responsibilities
Lead ECO implementation and NPI activities from assessment to closure; Coordinate first builds and production trials; Troubleshoot manufacturing issues and verify solutions on the production floor; Own and drive NC, INV, and CAPA activities; Facilitate root cause investigations with cross-functional teams; Lead Equipment Qualification and Process Validation activities; Develop and improve manufacturing processes using risk management and continuous improvement methods.
Seniority
Mid-Senior, hands-on IC