Risk Manager for Medical Device Development

1 month ago


Copenhagen, Copenhagen, Denmark 3Shape Full time
About the Role

We are seeking a highly skilled Risk Manager to contribute to the development of our scanner systems, a combination of hardware and software systems in the medical device domain. As a Risk Manager, you will be responsible for working on Risk Management of our scanner systems, collaborating with colleagues across R&D, product development, scientific management, product management, and production.

Key Responsibilities
  • Develop and implement Risk Management strategies for our scanner systems, adhering to ISO 14971 standards and IEC guidelines.
  • Work with stakeholders to identify and mitigate risks associated with electronics hazards and risk management.
  • Collaborate with cross-functional teams to ensure effective risk control measures are implemented in our solutions.
  • Contribute to the development of software risk management and medical device development.
Requirements
  • Deep knowledge of Risk Management within product development, with experience in ISO 14971 standards and IEC guidelines.
  • Knowledge of electronics hazards and risk management of them.
  • Ability to work with multiple stakeholders from different development domains.
  • Hands-on approach with experience in team collaboration.
  • Experience with software risk management and medical device development is beneficial.
About Us

3Shape is a visionary and international company that creates award-winning scanning and CAD/CAM solutions to change dentistry together. We are committed to celebrating human diversity and welcome diverse people into our community. We offer an attractive healthcare package, breakfast every day, and a delicious and healthy lunch cooked by our private chefs. We also provide a joint purpose: to enable dentists to provide superior dental care to every patient, every time.

We encourage all relevant applicants to apply and ask you NOT to add any photos or sensitive information during the application process. We are an exciting place to work, with a diverse group of over 50 different nationalities who all contribute to an awesome company culture.



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