Sr. Manufacturing Engineer (NPI) JB-5367

• 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.

• Continuous Improvement: Monitor post-release metrics to optimize yield, efficiency, and ensure full QMS/DMR compliance.

• 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.