NPI Engineer

About the role

The NPI Engineer will lead the transfer of new and legacy medical device products from development to manufacturing, ensuring compliance with regulations and company strategy. The role requires close interaction with customers to negotiate and finalize transfer decisions while meeting schedule and budget expectations.

Key responsibilities

• Lead implementation activities to guarantee successful process transfer.
• Define transfer stages, lead times, resources and customer requirements together with the project manager.
• Create and update technical documentation to support decision‑making.
• Monitor ramp‑up of production lines, control scrap and product variances using Lean tools (DMAIC, PDCA, Ishikawa, Pareto, Poka‑Yoke).
• Ensure correct Cost of Goods Sold for new part numbers in SAP and provide profit information.

Required profile

• Bachelor’s or Master’s degree in Engineering (Electronic, Materials, Mechanical, Electrical, Industrial, Production).
• 8+ years of experience in similar positions, including 5+ years in the medical industry.
• Advanced English communication skills.
• Valid passport and visa.

Required skills

• Proficiency with SAP for cost tracking and part number management.
• Experience using Minitab, AutoCAD and SolidWorks.
• Strong knowledge of Lean and Six Sigma methodologies (DMAIC, PDCA, Ishikawa, Pareto, Poka‑Yoke).
• Understanding of ISO 13485, CAPA, CAPEX, budget control and COGS.