A global leader in medical device micro-manufacturing is seeking a Senior Manufacturing Engineer (NPI) to bridge R&D and Production. In this role, you will lead process transitions (from validation to commercial scale), drive process optimization using DFM and Lean Six Sigma, and develop automated/fixture solutions for high-volume manufacturing.
Key Responsibilities
Process & Layout Design: Design and optimize manufacturing processes, equipment layouts, operational sequences, and production workflows.
NPI & Transfer: Lead NPI projects from concept to full production, working closely with R&D, Production, and customers.
Validation & Quality: Execute process validations (IQ/OQ/PQ/TMV, Gage R&R), draft PFMEAs, control plans, and define inspection methods.
Documentation & CAD: Write work instructions, update BOMs/routers, and finalize tooling documentation using SolidWorks.
Key Responsibilities
Process & Layout Design: Design and optimize manufacturing processes, equipment layouts, operational sequences, and production workflows.
NPI & Transfer: Lead NPI projects from concept to full production, working closely with R&D, Production, and customers.
Validation & Quality: Execute process validations (IQ/OQ/PQ/TMV, Gage R&R), draft PFMEAs, control plans, and define inspection methods.
Documentation & CAD: Write work instructions, update BOMs/routers, and finalize tooling documentation using SolidWorks.
Requirements:
4+ years of experience in Manufacturing/Process Engineering.
B.Sc. in Mechanical Engineering or a relevant field.
Proven experience in Process/Product Transitions & Validations (Medical Device / Process Industries preferred).
Hands-on experience with project costing/budgeting and statistical analysis for equipment validation.
Strong problem-solving skills and fluent English (written & spoken).
Pluses: Six Sigma Green Belt, ISO 13485 Lead Auditor, Tooling/Laser/Vision systems experience, or PMP.
4+ years of experience in Manufacturing/Process Engineering.
B.Sc. in Mechanical Engineering or a relevant field.
Proven experience in Process/Product Transitions & Validations (Medical Device / Process Industries preferred).
Hands-on experience with project costing/budgeting and statistical analysis for equipment validation.
Strong problem-solving skills and fluent English (written & spoken).
Pluses: Six Sigma Green Belt, ISO 13485 Lead Auditor, Tooling/Laser/Vision systems experience, or PMP.
This position is open to all candidates.
