Manufacturing Engineer -NPI Lead
Core
Lead New Product Introduction (NPI) activities from development through manufacturing transfer and production ramp for capital equipment and disposable medical devices.
Role type
Senior NPI Lead (Medical Devices)
Builds
Capital equipment and disposable medical devices for dialysis care
Domain
Medical device manufacturing (dialysis)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
NPI program leadership, FDA QSR/GMP/ISO 13485 compliance, process and equipment validation (IQ/OQ/PQ, MSA), DFM/DFA, cross-functional program management, high-volume manufacturing, supplier/CM engagement, technical issue resolution (NCs, CAPAs, yield loss), manufacturing documentation (work instructions, BOMs, routings, PFMEAs, control plans), continuous improvement metrics tracking
Preferred skills
Lean Six Sigma Green Belt, extrusion/injection molding/ultrasonic welding/tubing/electro-mechanical assembly experience, cost optimization background
Technologies
SolidWorks, AutoCAD, Minitab, Microsoft Office
Responsibilities
Lead and supervise NPI and Manufacturing Engineers; Own manufacturing readiness from concept to production release; Serve as primary manufacturing interface to R&D for DFM/DFA and risk reduction; Develop and scale manufacturing processes, tooling, fixtures, and test methods; Ensure execution of process and equipment validation; Partner with PMO to manage schedules, resources, risks, and timelines; Lead pilot builds, early production runs, and transitions to Operations; Provide leadership for technical issue resolution; Engage suppliers and Contract Manufacturers; Ensure completion and compliance of manufacturing documentation; Track NPI performance metrics and drive continuous improvement
Seniority
Senior, hands-on IC with supervisory experience
