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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 is a key contributor to transitioning complex, electromechanical medical devices from design through validated manufacturing, both in-house and at external suppliers. Your work will ensure these life-saving products stay at the forefront of innovation and meet the highest standards of the industry. You will interface and collaborate with cross-functional teams in Zurich and United States offices.

Tasks

  • 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.

Requirements

  • Bachelor’s degree in Electrical Engineering, Manufacturing 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: Experience with medical devices/equipment containing electronics, motors, LCD displays, and user interface components.
  • Preferred: Proficiency using statistics, including gage R&R, DOE, capability studies (Cp/Cpk), and other analyses to ensure measurement and process robustness.
  • Preferred: Experience with Lean Manufacturing and/or Six Sigma methodologies.
  • Preferred: Experience supporting production ramp-up and sustaining engineering after product launch.
  • Preferred: Sustaining experience post-launch, e.g. yield improvement, root cause investigations, and ongoing process optimization.
  • Preferred: Communicative German is a plus.

Benefits

  • 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.
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Über uns
Abbott ist ein globales Gesundheitsunternehmen mit Tätigkeiten in Diagnostik, Medizintechnik, Ernährung und etablierten Arzneimitteln. Wir entwickeln Produkte und Lösungen für Bereiche wie Diabetesmanagement, Herz-Kreislauf-Versorgung, diagnostische Tests, Ernährung, Neuromodulation und weitere medizinische Anwendungen. In der Schweiz ist Abbott unter anderem über Abbott AG in Baar sowie weitere Abbott-Gesellschaften tätig.
Das Team

You will collaborate with cross-functional teams in Zurich and United States offices, working in a supportive and inclusive team culture.

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