Senior Technical Specialist - Process Validation

Job description

JOB DESCRIPTION: 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 launch Sustaining experience post-launch, e.g. yield improvement, root cause investigations, and ongoing process optimization Communicative 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 growth opportunities within a global healthcare organization A stable and future-focused 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’re looking for curious, motivated people who want to grow and make a difference — not just those who meet every single requirement. If this role sounds exciting to you, we’d love to hear from you. The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Manufacturing DIVISION: HF Heart Failure LOCATION: Switzerland : Technoparkstrass 1 CH 8005 ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Not Applicable