Prin Manufacturing Engineer
Core
Principal Manufacturing Engineer leading optimization of manufacturing lines within the Global Contract Manufacturing Platform for medical devices.
Role type
Principal Manufacturing Engineer (Global Contract Manufacturing)
Builds
Production fixtures, validation protocols, and optimized manufacturing processes for medical devices and subassemblies.
Domain
Medical Device Manufacturing / Contract Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Fixture design and validation, IQ/OQ/PQ protocol execution, Root-cause analysis (CAPA), Statistical process control (SPC), Lean manufacturing, FMEA, Risk management, Process layout design, Equipment troubleshooting, Regulatory compliance (ISO 13485, FDA 21 CFR Part 820), Data analysis (Minitab, JMP), Project planning
Preferred skills
Experience with large capital equipment and small consumables, Contract manufacturing finished goods supplier experience
Technologies
Minitab, JMP, ISO 13485, FDA 21 CFR Part 820
Responsibilities
Develop and validate production fixtures; Execute validation protocols (IQ/OQ/PQ); Troubleshoot equipment and process deviations; Design manufacturing processes and facility layouts; Drive throughput improvements via automation; Analyze test data for trends; Implement CAPA for test-related issues; Ensure regulatory compliance and audit readiness.
Seniority
Principal, hands-on IC with mentorship and project leadership
