NPI Engineer – Medical Device

The NPI Engineer is responsible for leading the transition from product development to mass production, ensuring stability, quality, reliability, and compliance with stringent regulatory requirements of the medical device industry.

Key Responsibilities:

- Lead the transition process from engineering/development to full-scale production.

- Write and implement validation protocols (IQ/OQ/PQ).

- Full documentation per ISO 13485 and FDA requirements (including DMR, DHF, DHR).

- Develop and define manufacturing and automation processes.

- Write work instructions, assembly processes, and end-to-end testing procedures.

- Define and implement production equipment and infrastructure (Fixtures, Tooling, Jigs).

- Provide engineering support during ramp-up and troubleshooting.

- Support specification definitions for component purchasing and supplier manufacturing.

- Define accurate BOM (Bill of Materials).

- Support supplier training and knowledge transfer.

- Collaborate with Regulatory, Quality, and Validation teams to ensure compliance (FDA, MDR).

- Support the preparation and submission of technical documentation for regulatory purposes.

- Analyze failures, manage CAPA processes, and implement continuous improvements.

- Work closely with departments: R&D, Quality, Regulatory, Operations, Procurement, Clinical, and Service.

- Coordinate between internal teams and external suppliers (including contract manufacturers).

Requirements:

- B.Sc. in Mechanical / Electrical / Biomedical / Industrial Engineering (or equivalent).

- At least 2–5 years of relevant experience, preferably in the medical device field.

- Strong familiarity with medical regulations (ISO 13485, FDA QSR, MDR).

- Proven experience in project leadership and product transfer from development to production.

- Proficiency in CAD tools (e.g., SolidWorks) and ERP systems (e.g., Priority, SAP).