Sr. Manufacturing Engineer (NPI) JB-5367
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The role in plain words
- 4+ years of experience in Manufacturing/Process Engineering
- B.Sc. in Mechanical Engineering or a relevant field
- SolidWorks
- Process/Product Transitions & Validations (IQ/OQ/PQ/TMV, Gage R&R, PFMEA)
- Project costing/budgeting and statistical analysis for equipment validation
- Six Sigma Green Belt
- ISO 13485 Lead Auditor
- PMP
- Tooling/Laser/Vision systems experience
Extracted from the job description · kept up to date automatically
Who this suits
Full job description
Original listing · kept for reference• 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.
Questions about this role
- This listing did not state a salary. We only show pay when the employer publishes it.
- 4+ years of experience in Manufacturing/Process Engineering, B.Sc. in Mechanical Engineering or a relevant field, SolidWorks, Process/Product Transitions & Validations (IQ/OQ/PQ/TMV, Gage R&R, PFMEA), Project costing/budgeting and statistical analysis for equipment validation