NPI Engineer II

About the role

The NPI Engineer II will lead product and process transfer projects at Heraeus Medevio's Costa Rica site, ensuring compliance with medical device regulations and quality standards. You will validate new manufacturing processes, configure SAP data, and support the ramp‑up of new products.

Key responsibilities

• Execute process validations (IQ, OQ, PQ) for new medical devices.
• Configure SAP routings, BOMs and COGS for transferred parts.
• Assist with budget tracking, CAPEX requests and cost reporting.
• Analyze scrap, downtime and yield using Lean tools to monitor ramp‑up performance.
• Conduct basic DOE and Gage R&R studies under senior engineer guidance.
• Deliver training to operators and technical staff on new product requirements.
• Participate in CAPA, complaint and non‑conformance investigations.
• Coordinate with cross‑functional teams to ensure resources for validation, training and compliance.

Required profile

• Bachelor’s degree in an engineering discipline (electronic, mechanical, industrial, etc.).
• 3‑5 years of experience in medical manufacturing process validation.
• Fluent spoken and written English.
• Knowledge of Lean, Six Sigma, CAPA, CAPEX and budget control.

Required skills

• Process validation (IQ, OQ, PQ)
• SAP configuration (routings, BOMs, COGS)
• Lean and Six Sigma methodologies
• Minitab for statistical analysis
• Design of Experiments (DOE)
• Gage R&R studies
• CAPA investigation
• CAPEX budgeting and cost tracking