Senior Manufacturing Engineer
Core
Leading the transfer of new products from development into production, ensuring manufacturing readiness, process robustness, quality, and scalability for medical device manufacturing.
Role type
Senior Manufacturing Engineer (NPI & Process Validation)
Builds
Production-ready manufacturing processes, tooling, fixtures, and assembly methods for medical devices.
Domain
Medical Devices / Regulated Manufacturing
Required skills
New Product Introduction (NPI) leadership, Process Validation (IQ/OQ/PQ), Root-cause analysis, Manufacturing process optimization, Design for Manufacturability (DFM), Project management, Technical documentation, Lean manufacturing, Data analysis, CAD interpretation
Preferred skills
People management/mentoring, Medical device industry experience, ISO 13485 knowledge, ERP/MRP systems, CAD software
Technologies
CAD, ERP/MRP systems, IQ/OQ/PQ protocols
Responsibilities
Lead NPI and design transfer through production launch; Develop and optimize manufacturing processes, equipment, and tooling; Lead equipment qualification and process validation; Mentor junior engineers and technicians; Conduct root-cause investigations and CAPA activities; Manage manufacturing engineering projects and priorities.
Seniority
Senior, hands-on IC with mentorship responsibilities