Senior NPI Engineer
On-siteZürich, Zurich, Switzerland
Job Summary
Drive manufacturing process development from early design through commercial launch for complex electro-mechanical medical devices, optimizing assembly, test, calibration, and packaging operations. Own process validation activities (IQ/OQ/PQ) for in-house equipment and supplier processes in compliance with ISO 13485, authoring validation plans, protocols, and summary reports. Serve as the technical interface between Abbott and external suppliers, reviewing process flows, PFMEAs, and control plans to align internal and external manufacturing processes for efficient production. Collaborate with cross-functional teams in Zurich and United States offices to translate design requirements into manufacturing specifications and process documentation.
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
- 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
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