Senior NPI Engineer

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. 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. Serve as the technical interface between Abbott and external suppliers developing sub‑assemblies or performing outsourced manufacturing steps. Review supplier process flows, PFMEAs, control plans, and validation protocols. Align internal and external manufacturing processes for efficient production.

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. With your work, you’ll ensure these life-saving products stay at the forefront of innovation and meet the highest standards of our industry. In your role you will be interfacing and collaborating with cross-functional teams in Zurich and United States offices.

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Electrical Engineering, or a related technical discipline.

• 5+ years of experience in medical device NPI, manufacturing engineering, or process development.

• Ownership in developing and validating manufacturing processes and tooling for electro‑mechanical or capital medical equipment.

• Strong working knowledge of process validation (IQ/OQ/PQ) and regulated manufacturing environments.

• Experience creating manufacturing requirements, specifications, and procedures, including developing/defining CTQs and IPCs

• Hands-on experience on the manufacturing floor to support engineering/pilot builds.

• Experience collaborating with and managing external suppliers for manufacturing processes or sub‑assemblies.

• Strong technical writing and communication skills; ability to collaborate with a cross-functional project team (R&D, Quality, Regulatory, etc.)

• English proficiency is required (English is used in meetings and all documentation)