Senior NPI Engineer 100%

Darum lohnt es sich

In your role you will be interfacing and collaborating with cross‑functional teams in Zurich and United States offices. /p h3Main Responsibilities /h3 h3New Product Introduction Process Development /h3 pDrive manufacturing process development from early design phases through commercial launch for complex electro‑mechanical medical devices. /p pDevelop, characterize, and optimize manufacturing processes for capital equipment, including assembly, test, calibration, and packaging operations. /p pSupport Design for Manufacturability (DFM) activities in collaboration with RD, Quality, and Operations. /p pTranslate design requirements into manufacturing requirements, equipment specifications, and process documentation. /p h3Process Validation Manufacturing Readiness /h3 pOwn process validation activities (IQ/OQ/PQ) for in‑house equipment and supplier processes in compliance with ISO 13485 and Abbott procedures. /p pAuthor validation plans, protocols, and summary reports. /p pCreate manufacturing documentation, including manufacturing requirements, equipment and process specifications, manufacturing procedures/work instructions/bIPCs /b, test methods, and PFMEAs. /p h3Manufacturing Supplier Collaboration /h3 pServe as the technical interface between Abbott and external suppliers developing sub‑assemblies or performing outsourced manufacturing steps. /p pReview supplier process flows, PFMEAs, control plans, and validation protocols. /p pAlign internal and external manufacturing processes for efficient production. /p h3Required Qualifications /h3 pBachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Electrical Engineering, or a related technical discipline. /p p5+ years of experience in medical device NPI, manufacturing engineering, or process development. /p pOwnership in developing and validating manufacturing processes and tooling for electro‑mechanical or capital medical equipment. /p pStrong working knowledge of process validation (IQ/OQ/PQ) and regulated manufacturing environments. /p pExperience creating manufacturing requirements, specifications, and procedures, including developing/defining CTQs and IPCs /p pHands‑on experience on the manufacturing floor to support engineering/pilot builds. /p pExperience collaborating with and managing external suppliers for manufacturing processes or sub‑assemblies. /p pStrong technical writing and communication skills; ability to collaborate with a cross‑functional project team (RD, Quality, Regulatory, etc.) /p pEnglish proficiency is required (English is used in meetings and all documentation) /p h3Preferred Qualifications /h3 pExperience with medical devices/equipment containing electronics, motors, LCD displays, and user interface components /p pProficiency using statistics, including gage RR, DOE, capability studies (Cp/Cpk), and other analyses to ensure measurement and process robustness /p pExperience with Lean Manufacturing and/or Six Sigma methodologies /p pExperience supporting production ramp‑up and sustaining engineering after product launch /p pSustaining experience post‑launch, e.g. yield improvement, root cause investigations, and ongoing process optimization /p pCommunicative German is a plus /p h3Why Join Abbott / Thoratec? /h3 pAt 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. /p pYou can expect: /p ul liMeaningful work that directly impacts patients’ lives /li liCareer growth opportunities within a global healthcare organization /li liA stable and future‑focused industry /li liA collaborative and inclusive team culture /li liA modern workplace in the heart of Zurich /li liAn environment where different perspectives and experiences are valued /li /ul h3Job Details /h3 ul libWork location /b 8005 Zürich (ZH) /li libWorkload /b 100% /li libEmployment start /b By agreement /li libEmployment duration /b Permanent /li libEnglish /b Orally : Very good knowledge Written : Very good knowledge /li /ul /p #J-18808-Ljbffr ph3Senior NPI Engineer 100% /h3 h3Senior New Product Introduction (NPI) Engineer /h3 pAbbott 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. /p pThe 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. /p pWith your work, you’ll ensure these life‑saving products stay at the forefront of innovation and meet the highest standards of our industry.