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ETH Zurich

Quality Engineer Medical Device

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Quality Engineer Medical Device

The Wyss Zurich is a joint accelerator of the ETH Zurich and the University of Zurich, which was made possible by a generous donation from the Swiss entrepreneur and philanthropist Dr. hc. mult. Hansjörg Wyss. The mission of Wyss Zurich is to drive the clinical translation and technology transfer of outstanding scientific discoveries into new therapies for patients and breakthrough innovations in the emerging fields of Regenerative Medicine and Robotics, and to promote hybrid technologies in these fields. Wyss Zurich brings together some of the world’s leading experts to form multidisciplinary teams, pooling their knowledge and expertise. For further information: wysszurich.uzh.ch.

Project background

Liver4Life develops novel therapeutic strategies for liver regeneration consisting of:

  • Surgical resection of a small healthy piece of the liver from the patient
  • Growth of this piece outside of the body in a perfusion machine until a sufficient size is reached
  • Retransplantation of the regenerated liver to the original patient while removing the remaining diseased part. Current perfusion systems are not able to keep a liver alive outside of the body for a sufficient time (5-7 days) to allow growth and regeneration to occur.

With our developed perfusion devices, we are able to preserve a liver outside of the body for up to 7 days prior to transplantation. The perfusion device is fully automated and supplies the liver with nutrients, drugs, hormones and oxygen. The next step in the project is a clinical study as final proof of the preservation technology. To this end, the perfusion device needs to qualify for use in a clinical study. Safety and performance of the device has to be shown with respect to all applicable regulations and norms.

With our developed perfusion devices, we are able to preserve a liver outside of the body for up to 7 days prior to transplantation. The perfusion device is fully automated and supplies the liver with nutrients, drugs, hormones, and oxygen.
The next step in the project is a clinical study as final proof of the preservation technology. To this end, the perfusion device needs to qualify for use in a clinical study. The safety and performance of the device has to be shown with respect to all applicable regulations and norms.

Job description

  • Provide support to ensure QMS compliance with the appropriate internal and external regulatory requirements
  • Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS
  • Drive the implementation of quality procedures according to ISO 13485
  • Support in in attaining compliance with applicable standards, e.g. ISO 14971, IEC 62304, ISO 10993-1, ISO 60601-1/2, etc
  • Derive verification and validation plans
  • Responsible to identify and address quality gaps in the design process
  • Support internal and external quality system audits
  • Collaborate with internal and external regulatory and quality experts
  • Participate in perfusion runs

Your profile

  • A minimum of 2 years of professional experience in a quality discipline with detailed knowledge on ISO 13485 in the medical device industry is a must
  • Ideally, you held a product development role with significant exposure Quality Management Systems and Quality/Regulatory Affairs at a medical device manufacturer
  • MSc in Engineering, Science or related qualification
  • You have basic knowledge and understanding of the US and European medical device regulations and a detailed knowledge of quality systems
  • Previous experience and familiarity with the following standards is a plus: ISO 14971, IEC 62304, ISO 10993-1, ISO 60601-1/2, etc
  • Very structured way of working
  • Demonstrated ability to work in cross-function team environment
  • Strong interest in interdisciplinary work and willingness to dive into new topics and understand medical requirements
  • Passionate about best practice software development practices and technologies
  • Good interpersonal skills, teamwork, multi-cultural compatibility
  • Fluency in German and English
  • Flexibility, motivated and self-driven attitude

ETH Zurich

ETH Zurich is one of the world’s leading universities specialising in science and technology. We are renowned for our excellent education, cutting-edge fundamental research and direct transfer of new knowledge into society. Over 30,000 people from more than 120 countries find our university to be a place that promotes independent thinking and an environment that inspires excellence. Located in the heart of Europe, yet forging connections all over the world, we work together to develop solutions for the global challenges of today and tomorrow.

Interested?

We look forward to receiving your online application with the following documents:

  • CV
  • Cover Letter
  • Track records, diplomas, references

Please note that we exclusively accept applications submitted through our online application portal. Applications via email or postal services will not be considered.

Further information about Liver4Life can be found on our website.

In line with our values, ETH Zurich encourages an inclusive culture. We promote equality of opportunity, value diversity and nurture a working and learning environment in which the rights and dignity of all our staff and students are respected. Visit our Equal Opportunities and Diversity website to find out how we ensure a fair and open environment that allows everyone to grow and flourish.

Informatie over de vacature

Functienaam
Quality Engineer Medical Device
Werkgever
Locatie
Rämistrasse 101 Zürich, Zwitserland
Gepubliceerd
2021-11-20
Soort functie
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ETH Zurich is one of the leading international universities for technology and the natural sciences. It is well known for its excellent education, ...

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