Technical Lead, NPI Manufacturing Engineer
Core
Lead Manufacturing Engineering (ME) processes and execution during New Product Introduction (NPI) and sustaining phases for complex medical robotic systems.
Role type
Senior Technical Lead, NPI Manufacturing Engineer
Builds
Robotic surgical platforms for early diagnosis and treatment
Domain
Medical Robotics / Healthcare
Required skills
Lean manufacturing, continuous improvement, data analytics, process design, PFMEA, IQ/OQ/PQ validation, DFM feedback, BOM management, regulatory compliance (FDA/ISO 13485)
Preferred skills
Experience with complex electromechanical devices, troubleshooting, fixture implementation
Technologies
FDA QSR, ISO 13485, DMR/DHR/LHR, BOM, MPI, schematics
Responsibilities
Provide leadership to ME team during NPI; implement lean principles and drive continuous improvement; create workflow diagrams and work instructions; lead PFMEA activities; validate manufacturing equipment and processes (IQ/OQ/PQ); provide DFM feedback to R&D; support field returns and discrepancy investigations; train production technicians.
Seniority
Senior, hands-on IC