Systems Engineer

Thoratec Switzerland GmbH is part of the medical device division of AbbottLaboratories, 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

Systems 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

• Planning and execution of system level activities during product development including usability engineering, system requirement engineering, system level test plan creation and execution.

• Define and guide creation of user needs, system requirements, system specifications, and system design to optimize the system performance and ensure compliance to applicable standards.

• Champion the analysis for safety, efficacy, usability, and system security of the medical device from a Systems Engineering point of view.

• Participate in the technical support activities of design/drafting, field testing, lab testing, protocol preparation, test analysis, and documentation to support historical records, as well as regulatory and patent submissions.

• Evaluate device performance and safety considerations using bench and field testing and maintain appropriate records.

• Participate in new product development activities in collaboration with various departments and geographies in the concept, design, and testing of products.

• Participate in product sustaining activities including regulatory and quality aspects, e.g. corrective and preventive actions (CAPAs).

• Own and support compliance to applicable standards.

• Active participation in internal and external audits.

Required Qualifications

• Master's Degree in Engineering or equivalent (ETH/FH or comparable education)

• Experience in a similar position in the MedTech industry, preferably with Mechatronic Devices

• Proven experience in Requirements Engineering including design transfer of requirements

• Experience in Design Verification & Validation planning and execution

• Detailed knowledge of medical standards like IEC 60601, IEC 62366, ISO 13485, FDA 21CFR820, ISO 14971, GMP, GDP

• Flexible collaborator with accurate working and documentation style

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

Preferred Qualifications

• Knowledge of Requirements Management Tools, e.g. Doors

• Knowledge of Agile Working methods and tools, e.g. Jira

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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