Risk Management Specialist for Medical Device Development

1 week ago


Copenhagen, Copenhagen, Denmark 3Shape Full time

We are seeking a highly skilled Risk Manager to contribute to the development of scanner systems, a combination of hardware and software systems in the medical device domain.

Your main task is working on Risk Management of our scanner systems. You will mainly work in one or more development projects, but the role also covers keeping marketed products sharp. The work on the marketed products covers topics such as CAPA, Engineering change control, and Vigilance sparring.

You understand the relationships and dependencies of HW and SW and can balance risk control measures in our solutions with commercial needs.

You will work with colleagues across R&D, product development, scientific management, product management, and production, and from different locations.

We have a focused and fun approach to our workday and hope you will come and join us.

About this role:

  • You have deep knowledge of Risk Management within product development, adhering to ISO 14971 standards and preferably IEC 60601-1.
  • You have knowledge of electronics hazards and risk management of them.
  • You can work with many different stakeholders from different development domains.
  • You like working in teams and have a hands-on approach.
  • Experience with working with software risk management and medical device development is beneficial.


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