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 . 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!

　　Please follow our Career site and check for available openings:

　　Abbott Jobs | Apply Now | Abbott Laboratories Careers (https://www.jobs.abbott/us/en)

　　An Equal Opportunity Employer

　　Abbot welcomes and encourages diversity in our workforce.

　　We provide reasonable accommodation to qualified individuals with disabilities.

　　To request accommodation, please call 224-667-4913 or email [email protected]