Senior NPI Engineer

• 02 July 2026 • 100% • Indefinite duration • Zurich Senior NPI Engineer - New Product Introduction Abbott is looking for a Senior New Product Introduction (NPI) Engineer to support the development and production ramp-up of the next generation of the CentriMag Circulatory Support System. This role will be a key contributor to the transition of complex electromechanical medical devices from design to validated manufacturing - both internally and at external suppliers. The ideal candidate possesses 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, in a regulated medical device environment. Through your work, you will ensure that these life-critical products remain at the forefront of innovation and meet the highest standards of our industry. In your role, you will collaborate with cross-functional teams in the Zurich and US offices. Main Responsibilities New Product Introduction & Process Development • Lead the development of manufacturing processes from initial design phases through to commercial launch for complex electromechanical medical devices. • Develop, characterize, and optimize manufacturing processes for capital equipment, including assembly, testing, 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 • Be responsible for process validation activities (IQ/OQ/PQ) for internal equipment and supplier processes in accordance with ISO 13485 and Abbott procedures. • Write validation plans, protocols, and summary reports. • Create manufacturing documentation, including manufacturing requirements, equipment and process specifications, procedures/work instructions/IPCs, test methods, and PFMEAs. Manufacturing & Supplier Collaboration • Serve as a 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. • More than 5 years of experience in medical device NPI, manufacturing engineering, or process development. • Responsibility in the development and validation of manufacturing processes and tooling for electromechanical or capital medical equipment. • Strong hands-on knowledge of process validation (IQ/OQ/PQ) and regulated manufacturing environments. • Experience in creating manufacturing requirements, specifications, and procedures, including the development/definition of CTQs and IPCs. • Hands-on experience on the manufacturing floor to support engineering/pilot builds. • Experience in collaboration and management of external suppliers for manufacturing processes or sub-assemblies. • Excellent technical writing and communication skills; ability to collaborate with a cross-functional project team (R&D, Quality, Regulatory, etc.). • Proficiency in English required (English is used in meetings and in all documentation). Preferred Qualifications • Experience with medical devices/equipment containing electronics, motors, LCD screens, and user interface components. • Mastery of 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 in supporting production ramp-up and sustaining engineering after product launch. • Post-launch sustaining experience, e.g., yield improvement, root cause investigations, and continuous process optimization. • Communicative knowledge of German is a plus. Why join Abbott / Thoratec? At Abbott, we know that people do their best work when they feel supported, included, and empowered. We are committed to creating an environment where everyone can succeed. You can expect: • Meaningful work that directly impacts patients' lives • Career opportunities within a global healthcare organization • A stable and future-oriented industry • A collaborative and inclusive team culture • A modern workplace in the heart of Zurich • An environment where different perspectives and experiences are valued Ready to apply? We are looking for curious, motivated people who want to grow and make a difference - not just those who meet all the criteria. If this position excites you, we would love to hear from you.