Principal Manufacturing Engineer
Core
Coordinate and execute Verification and Validation (V&V) deliverables for supplier transfers within the Supplier Optimization group for medical devices.
Role type
Principal Manufacturing Engineer (Medical Devices)
Builds
Supplier qualified product assemblies and sub-assemblies
Domain
Medical Devices / Manufacturing Engineering
Required skills
FDA 21 CFR part 820, EU MDR, ISO 13485, ISO 14971, GMP, PPAP, IQ/OQ/PQ, Minitab, TMV, Capability (Ppk / Tolerance Intervals), SPC, Control Plans, Process Flow Maps, PFMEA, V&V protocols, First Article Inspection, BOM structure updates, AGILE, SAP, ERP systems
Preferred skills
None stated
Technologies
Minitab, SAP, ERP systems
Responsibilities
Design assembly and holding fixtures; coordinate supplier fabrication; develop protocols, reports, process instructions, preventive maintenance plans, and calibration schedules; navigate government and industry regulations; provide Control Plans, Process Flow Maps, and PFMEA; coordinate creation and approval of V&V protocols and reports; execute First Article Inspection activities; update BOM structure within QMS
Seniority
Principal, hands-on IC