NPI Engineer

About the role

Lead and execute the transfer of new and legacy medical device products and processes, ensuring alignment with company strategy, regulatory compliance, and quality systems. Work closely with customers to negotiate and make strategic decisions that drive successful product launches on time and within budget.

Key responsibilities

• Lead implementation activities to guarantee successful process transfers.
• 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, etc.).
• Ensure accurate Cost of Goods Sold (COGS) in SAP for new part numbers.

Required profile

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

Required skills

• SAP
• Minitab
• AutoCAD
• SolidWorks
• Lean methodology
• Six Sigma
• ISO 13485 knowledge
• CAPA, CAPEX, budget control
• Cost of Goods Sold (COGS) analysis