NPI Engineer II
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About Heraeus
Making displays foldable? Helping hearts beat with medical innovations? Or breathing new life into precious metals? As a family-owned global technology group we help our customers to always being one step ahead.
About Heraeus Medevio
Together we improve lives. At Heraeus Medevio, we bring lifesaving and life-changing medical devices to market through partnerships with medical device manufacturing companies. Backed by Heraeus Group, we are committed to the growth of our teams and organization by providing an open space for open minds.
To reach our vision of improving 100 million lives every year, we foster a culture of curiosity that thrives on challenge, continuous learning, growth, and the opportunity to try new things. With sites in the United States, European Union, and Asia, and over 2,200 employees worldwide, together, we will meet tomorrow's challenges today.
Job Purpose
Execute and partially coordinate product and process transfer projects to HMCR, ensuring compliance with regulations and Quality requirements. Responsible for validating processes, documenting results, and collaborating with internal teams and customers for the implementation of new products.
Main Responsibilities:
- Execute implementation activities to support the transfer process at HMCR Costa Rica site by performing process validations (IQ’s, OQ’s and PQ’s), configuring SAP system data (routings, BOM’s and COGS), assisting with budget tracking and CAPEX requests, and running manufacturing and inspection processes in compliance with the quality system.
- Coordinate with project manager to define transfer stages, timelines, resources, and customer requirements.
- Prepare and update technical documentation to enable decisions and ensure compliance.
- Track ramp-up performance by analyzing scrap, downtime, and yield using Lean tools.
- Maintain COGS accuracy in SAP for new parts and report deviations.
- Perform basic DOE and Gage R&R studies under Sr. Engineer guidance.
- Deliver training sessions for operators and technical staff on new product requirements.
- Contribute to CAPA, Complaint, and Nonconformance investigations by proposing corrective actions.
- Align with other departments to ensure resources for validation, training, and compliance requirements are met.
- Develop and support the technician team to consistently deliver high‑quality performance while coordinating daily operational activities that ensure successful execution of project and production objectives.
- Participate in cross-functional teams for new products/processes, ensuring integration into manufacturing.
Required Qualifications:
- Bachelor’s degree with a major in Engineering fields (Electronic, Materials, Maintenance, Mechanical, Electric, Industrial, Production and others).
- Validation medical manufacturing process experience.
- Fluent in spoken and written business English.
- Lean and six sigma knowledge.
- Knowledge in CAPEX, Budget control and COGS.
- CAPA knowledge.
- Software: Minitab.
- 3-5 years of work experience in medical industry.
- Transfer Process Projects implementation.
- Continuous Improvement Projects implementation.
- Six Sigma Green Belt.
Preferred Qualifications:
- Engineering Master’s degree in field related.
- Proficient in using SAP
- Project management experience.
- Normative ISO13485.
- Software: AutoCad & Solidworks.
- Six Sigma Black Belt.
ReqID: 59791
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