NPI Engineer II

About the role

The NPI Engineer II will lead product and process transfer projects for Heraeus Medevio’s Costa Rica manufacturing site. You will ensure new medical device products are introduced in compliance with regulatory and quality standards while supporting efficient ramp‑up.

Key responsibilities

• Execute and coordinate product transfer activities, including IQ, OQ and PQ validations.
• Configure SAP data (routings, BOMs, COGS) for new parts and maintain cost accuracy.
• Assist project managers in defining transfer stages, timelines, resources and customer requirements.
• Track ramp‑up performance using Lean tools, analysing scrap, downtime and yield.
• Perform basic DOE and Gage R&R studies under senior engineer guidance.
• Deliver training to operators and technical staff on new product requirements.
• Support CAPA, complaint and non‑conformance investigations with corrective actions.
• Collaborate with cross‑functional teams to integrate new products into manufacturing.

Required profile

• Bachelor’s degree in an engineering discipline (electronic, mechanical, industrial, etc.).
• 3‑5 years of experience in medical device manufacturing validation.
• Fluent spoken and written business English.
• Knowledge of Lean, Six Sigma, CAPEX budgeting and cost‑of‑goods‑sold management.

Required skills

• Minitab
• SAP (routings, BOMs, COGS)
• Lean and Six Sigma methodologies
• Design of Experiments (DOE)
• Gage R&R studies
• IQ/OQ/PQ validation procedures
• CAPA processes
• CAPEX and budget control