Dietikon, ZurichSend Application
Responsible for the development and support of manufacturing processes. Development of process and equipment validations in accordance with ISO 13485 requirements. Perform project planning and design transfer activities for new product introductions. Define, capture, and monitor test data and metrics for statistical process controls (SPC).
- Work collaboratively with R&D, Quality and Operations to create manufacturing processes and product support plans.
- Responsible for smooth design transfers from Engineering to Operations by writing operation plans, training of the Operations staff and assisting in the assembly and testing of prototypes and zero series modules.
- Development of process and equipment validations in accordance with ISO 13485 requirements
(IQ, OQ, PQ).
- Use lean manufacturing concepts to analyze manufacturing and test process flows for the enhancements of quality, cost reduction, and throughput.
- Investigate and document product and component level non-conformances, determine root cause, and recommend corrective and preventive actions (CAPA).
- Support the development, maintenance, support, and troubleshoot fixtures and automated test equipment (ATE) used in the manufacturing of optical modules.
- Coordinate and carry out life cycle management activities such as design, obsolescence or cost – down changes, in accordance with the internal change management process (ECN).
- Support the repair and service of returned modules.
- Bachelor’s degree in Engineering, Technical, Scientific discipline
- 5+ several years of experience as a mechanical design and/or process engineer in the development and manufacturing of complex products in a regulated environment
- Aptitude for working with people and very high level of social competence
- Pronounced self-motivation and commitment in connection with a strong sense of responsibility, quality and reliability
- Experience with Minitab, CAD and advanced proficiency in Microsoft Office
- Excellent verbal and written communication skills in German and English
- Experience in the development of medical or IVD products to ISO13485 standard, preferred
- Demonstrated ability using Lean Six Sigma methodologies, preferred
- Ability to travel to site in USA, customers, and suppliers (~10% Required)
What we offer:
Independent and varied position with growth potential in a dynamic and international work environment. A highly motivated, collegial team and attractive employment conditions await you.
We look forward to receiving your full application by email.