Senior NPI Engineer

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.

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.

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.
• Review supplier process flows, PFMEAs, control plans, and validation protocols.
• Align internal and external manufacturing processes for efficient production.

Required Qualifications

• 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)

Preferred Qualifications

• Experience with medical devices/equipment containing electronics, motors, LCD displays, and user interface components
• Proficiency using statistics, including gage R&R, DOE, capability studies (Cp/Cpk), and other analyses to ensure measurement and process robustness
• Experience with Lean Manufacturing and/or Six Sigma methodologies
• Experience supporting production ramp‑up and sustaining engineering after product