Overview
In this Senior NPI Engineer role, you drive the transition of complex electro‑mechanical medical devices from design to validated manufacturing, including in‑house and supplier processes. You work with cross‑functional teams in Zurich and the US to scale manufacturing for the CentriMag Circulatory Support System. You own process development, validation, and readiness activities to ensure robust, compliant production. You will shape DFM, equipment Specifications, and manufacturing documentation to enable successful product launches. This role offers meaningful impact on patient care and the opportunity to lead critical manufacturing improvements at a global healthcare leader.
Verantwortungsbereiche
- 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 (assembly, test, calibration, packaging)
- Support Design for Manufacturability (DFM) 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 and supplier processes in ISO 13485 context
- Author validation plans, protocols, and summary reports
- Create manufacturing documentation (MDRs, equipment/process specs, work instructions, IPCs, PFMEAs)
- Serve as technical interface between Abbott and external suppliers developing sub-assemblies or outsourced steps
- Review supplier PFMEAs, control plans, and validation protocols
- Align internal and external manufacturing processes for efficient production
Zentrale Anforderungen
- Bachelor’s degree in Mechanical, Manufacturing, Electrical Engineering or related
- 5+ years in medical device NPI, manufacturing engineering, or process development
- Experience developing/validating manufacturing processes and tooling for electro‑mechanical/capital medical equipment
- Strong knowledge of process validation (IQ/OQ/PQ) and regulated manufacturing
- Experience creating manufacturing requirements, specs, procedures, CTQs, IPCs
- Hands‑on manufacturing floor experience supporting engineering/pilot builds
- Experience collaborating with external suppliers for manufacturing processes or sub‑assemblies
- Strong technical writing and cross‑functional collaboration
- English proficiency required
- cross‑functional collaboration
- strong communication
- technical writing
- process validation (IQ/OQ/PQ)
- design for manufacturability (DFM)
- manufacturing documentation
Senior Operations & NPI Engineer in Zürich Arbeitgeber: Abbott
Abbott Diagnostics Manufacturing ist ein hervorragender Arbeitgeber, der bedeutungsvolle Arbeit in einem kollaborativen und integrativen Umfeld bietet. Als Senior Financial Analyst haben Sie die Möglichkeit, Ihre Karriere in einem globalen Unternehmen voranzutreiben, das sich für Innovation und Exzellenz einsetzt, während Sie von kontinuierlichen Entwicklungsmöglichkeiten und wettbewerbsfähigen Vorteilen profitieren. Wir fördern eine Kultur, in der vielfältige Perspektiven geschätzt werden und jeder Mitarbeiter gedeihen kann.
