NPI Engineer II - Transfer Projects

About the role

The NPI Engineer II executes and partially coordinates product and process transfer projects to the HMCR site, ensuring compliance with regulations and quality requirements. The role covers validating processes, documenting results and working with internal teams and customers to implement new products.

Key responsibilities

• Run process validations (IQ, OQ and PQ) and configure SAP data (routings, BOMs and COGS) to support transfer at the HMCR Costa Rica site
• Assist with budget tracking and CAPEX requests, and run manufacturing and inspection processes in line with the quality system
• Coordinate with the project manager on transfer stages, timelines, resources and customer requirements
• Prepare and update technical documentation and track ramp-up performance using scrap, downtime and yield analysis with Lean tools
• Maintain COGS accuracy in SAP for new parts and report deviations
• Perform basic DOE and Gage R&R studies under Senior Engineer guidance
• Deliver training for operators and technical staff on new product requirements
• Contribute to CAPA, complaint and nonconformance investigations and align with other departments on validation, training and compliance resources
• Take part in cross-functional teams for new products and processes

Required profile

• Bachelor's degree in an engineering field (electronic, materials, maintenance, mechanical, electric, industrial, production and others)
• 3-5 years of experience in the medical industry
• Fluent spoken and written business English
• Preferred: engineering master's degree, project management experience and ISO 13485 knowledge

Required skills

• Transfer project implementation, continuous improvement and medical manufacturing validation
• Lean and Six Sigma knowledge; Six Sigma Green or Black Belt preferred
• SAP, Minitab, AutoCAD and SolidWorks (preferred)