Senior NPI Engineer — Abbott
- Location
- Zurich
- Contract
- full-time
- Posted
- 2 days ago
Role overview
Senior NPI Engineer – New Product Introduction Abbott is seeking a Senior New Product Introduction (NPI) Engineer to support the development and manufacturing scale ‑ up of the next ‑ generation CentriMag Circulatory Support System .
This role will be a key contributor to transitioning complex, electromechanical medical devices from design through validated manufacturing—both in ‑ house and at external suppliers .
The ideal candidate brings hands ‑ on experience in process development , process validation , and manufacturing readiness for capital equipment containing electronics, displays, user interfaces (buttons, touchscreens, connectors), and electromagnetic motors , within a regulated medical device environment.
- Senior NPI Engineer – New Product Introduction Abbott is seeking a Senior New Product Introduction (NPI) Engineer to support the development and manufacturing scale ‑ up of the next ‑ generation CentriMag Circulatory Support System .
- This role will be a key contributor to transitioning complex, electromechanical medical devices from design through validated manufacturing—both in ‑ house and at external suppliers .
- Main Responsibilities New Product Introduction & Process Development
- Drive manufacturing process development from early design phases through commercial launch for complex electro‑mechanical medical devices.
Main responsibilities
- Main Responsibilities New Product Introduction & Process Development
- Drive manufacturing process development from early design phases through commercial launch for complex electro‑mechanical medical devices.
- Develop, characterize, and optimize manufacturing processes for capital equipment, including assembly, test, calibration, and packaging operations.
- Support Design for Manufacturability (DFM) activities in collaboration with R&D, Quality, and Operations.
- Translate design requirements into manufacturing requirements, equipment specifications, and process documentation.
- Process Validation & Manufacturing Readiness
- Own process validation activities (IQ/OQ/PQ) for in‑house equipment and supplier processes in compliance with ISO 13485 and Abbott procedures.
- Author validation plans, protocols, and summary reports.
- Create manufacturing documentation, including manufacturing requirements, equipment and process specifications, manufacturing procedures/work instructions/IPCs, test methods, and PFMEAs. Manufacturing & Supplier Collaboration
- Serve as the technical interface between Abbott and external suppliers developing sub‑assemblies or performing outsourced manufacturing steps.
Additional details
- Create manufacturing documentation, including manufacturing requirements, equipment and process specifications, manufacturing procedures/work instructions/IPCs, test methods, and PFMEAs. Manufacturing & Supplier Collaboration
- Align internal and external manufacturing processes for efficient production.
Notes and original content
- Create manufacturing documentation, including manufacturing requirements, equipment and process specifications, manufacturing procedures/work instructions/IPCs, test methods, and PFMEAs.
- Manufacturing & Supplier Collaboration