Thoratec Switzerland GmbH is a part of Abbott Laboratories, one of the world's leading manufacturers of medical devices. 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 acute and long-term therapy in patients with severe heart diseases.
Our location in the city of Zurich has around 100 employees in the areas of development and production of the Centri MagTM system and the HeartMate 3TM motor.
We are currently expanding our talented team for validation of existing software applications within production and are looking for a motivated person to join
Software Validation Engineer
As part of the Manufacturing Engineering team, you are mainly responsible for the software of test and process devices. You manage, plan and create the documentation to specify and validate our software applications. In this highly regulated environment, you will deal with all aspects of the software life cycle.
Your main tasks include:
Management and planning of all documents for all software that is not used on our medical devices (Non direct software)
Creation and editing of the specifications and validations in English
Execution of the validations (CSV)
Consideration of all requirements according to the specified internal and external standard
Close cooperation with internal Quality Engineering and Regulatory Assurance
Accompanying the documentation through the document change management (Windchill)
Your profile:
B.Sc./M.Sc. in computer science, electrical engineering or comparable training
Professional experience in relevant positions within software validation
Experience in development with C/C++, C# and Python
Basic knowledge of markup languages ​​(XML and HTML) and databases
Good knowledge of the regulations applicable in medical technology (ISO 13485 / FDA 21CFR Part 11 and Par 820 / GMP)
Excellent English skills, German language is a big plus
Strong personality with the will and the ability to bring projects to a conclusion.
Enjoying working with documentation
Enjoy working in a team.
We are looking for a highly motivated specialist who enjoys being part of a small team with broad responsibilities. Do you have what it takes? Then send us your application including motivation, curriculum vitae, letter of recommendation and diplomas in PDF format today. We are looking forward to meeting you.
","industry":"Healthcare","title":"Software Validation Engineer SwitzerlandDivision: HF Heart Failure
Travel: Yes, 10 % of the Time
Medical Surveillance: Not Applicable
Significant Work Activities: Not Applicable
