Senior Mechatronics Engineer

Lead and support On-Market products with activities including manufacturing, regulatory and quality aspects for the entire portfolio, e.g. obsolescence projects, complaint investigations, corrective and preventive actions (CAPAs), regulatory and standard updates. Manage multiple projects and tasks for timely completion. For design changes, own and support Design Control Process documentation, e.g. risk management files. Designing, planning, integration, execution and documentation of tests in compliance with Design Control process and regulatory requirements. Work closely with Manufacturing Engineering and Production to sustain the electronics and mechanical parts of our portfolio. Support Product development activities on the full life-cycle of class 2 and class 3 Medical Devices. Active participation in internal and external audits.

Thoratec Switzerland GmbH is part of the medical device division of Abbott Laboratories, a fortune 500 company with over 115’000 employees worldwide. We are the global market leader for implantable and extracorporeal blood pumps based on magnetic levitation technology. Our life-saving systems, which we develop and manufacture in Zurich, are used for advanced heart failure patients needing short- or long-term circulatory support. Our location in the heart of the city of Zurich has around 130 employees in the areas of development, quality and production of the CentriMag System and the HeartMate 3.

• Bachelor's Degree in Mechatronics, Electrical Engineering or equivalent (ETH/FH or comparable education)

• 5+ years of experience in a similar position in the MedTech industry

• Strong background in mechatronics and electronics

• Solid understanding of mechanics

• Basic understanding on embedded Software architecture and documentation

• Experience in Design Verification planning and execution

• Knowledge of medical standards like IEC 60601, ISO 13485, FDA 21CFR820, ISO 14971, MDR, GMP, GDP

• Excellent analytical and creative problem-solving skills

• Flexible collaborator with accurate working and documentation style

• Strong technical communication skills and ability to collaborate with a cross-functional project team (Manufacturing, Quality, Regulatory, etc.)

• English Level C2 is required, communicative German is a plus