DirecciónThoratec 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. We are looking for a motivated and talented
Sr. Mechanical Engineer
to join our team in Zurich. Become part of a young and aspiring team which is responsible for developing and sustaining mechatronic devices and consumables for our implantable and extracorporeal blood pump systems. With your work, you’ll ensure our products stay at the forefront of innovation and meet the highest standards of our industry. In your role you will be interfacing and collaborating with cross-functional teams in Switzerland and the US.
Main Responsibilities
Collaborate on interdisciplinary Product development activities on the full life-cycle of class 2 and class 3 Medical Devices
Lead product sustaining activities including regulatory and quality aspects, e.g. obsolescence projects, corrective and preventive actions (CAPAs)
Lead technical support activities of design/drafting, field testing, lab testing, and documentation including regulatory submissions
Lead new product development activities including verification and validation activities, e.g. test method development
(Sub-) Project Management on New Product Development and Sustaining projects
Own and support risk management activities
Own and support CAPAs and related investigations
Work closely with Manufacturing Engineering and Production for the mechanical parts of our portfolio
Designing, layouting, construction and commissioning of prototypes
Designing, planning, conducting and documentation of tests in compliance with regulatory requirements
Active participation in internal and external audits
Required Qualifications
Master's Degree in Mechanical Engineering or equivalent (ETH/FH or comparable education)
5+ years of experience in a similar position in the MedTech industry
Experience with owning and driving CAPAs and HHEs
Proven expertise in risk analysis (Product Risk Analysis / FMEAs)
Experience in Requirements Engineering including Product Architecture and design transfer of requirements
Experience in Design Verification & Validation planning and execution
Broad knowledge of manufacturing methods and applicable designs for manufacturability guidelines
Excellent skills in SolidWorks or similar CAD programs
Detailed 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
English Level C2 is required, communicative German is a plus
Preferred Qualifications
Experience in manufacturing of mechatronic medical devices and injection molding parts
Hands-on simulation experience (structural mechanics, fluid flow, …)
Knowledge of Root Cause Analysis Methods (Fishbone, 5 Whys, etc.)
Knowledge of Windchill (PLM and Change Control system) and SolidWorks
Knowledge of statistical methods, techniques, and statistical software tools
We are looking for service-oriented person with a strong maker mentality who would like to be part of our enthusiastic team with broad responsibilities. Do you have what it takes? Then send us your application including motivation letter, curriculum vitae, letter of recommendation and diplomas today. We are looking forward to meeting you in the heart of Zurich!
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