Risk Manager for medical device development DK

4 weeks ago

Copenhagen, Copenhagen, Denmark 3Shape Full time

We are seeking a Risk Manager to contribute to developing 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 our locations in Denmark, Poland, and Ukraine.

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

Your profile:

  • You have a 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.

Join us in shaping a company culture that makes Monday mornings worth it
We are an exciting, visionary, and international place to work. But most of all, we are a diverse group of over 50 different nationalities who all contribute to an awesome company culture. We partake in social clubs, monthly social activities, and various in-team activities as well. If that's not enough, then add on:

  • An attractive healthcare package to keep you fit and well.
  • Breakfast every day, and a delicious and healthy lunch cooked by our private chefs.
  • Good work/life balance e.g., work from home policy for up to 2 days per week.
  • A joint purpose: to enable dentists to provide superior dental care to every patient, every time.

Staying true to our values and DEI efforts, we encourage all relevant applicants to apply, and we ask you NOT to add any photos or sensitive information (age, marital status, nationality) during the application process.

We encourage all relevant applicants to apply. We are committed to celebrating human diversity, and we trust that the best way to reach outstanding business results is by welcoming diverse people into our community.

About us
3Shape started with a simple idea - to make 3D scanning better. First, we applied it to the hearing industry, then we succeeded in dentistry. Twenty years later, 3Shape has 2,000+ employees globally. With the help of dental professionals and amazing colleagues, we're creating award-winning scanning and CAD/CAM solutions to change dentistry together Together, we contribute to a better world. Experience the everyday #lifeat3Shape across the globe on LinkedIn.

Locations
DK - Copenhagen

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