Risk Management Specialist for Medical Device Development

4 weeks ago


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

We are seeking a highly skilled Risk Manager to join our team and 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.

You will work closely with stakeholders to identify and mitigate risks, ensuring that our solutions meet commercial needs while adhering to ISO 14971 standards and IEC 60601-1.

Key Responsibilities
  • Develop and implement risk management strategies for our scanner systems
  • Collaborate with cross-functional teams to identify and mitigate risks
  • Ensure compliance with ISO 14971 standards and IEC 60601-1
  • Work with stakeholders to balance risk control measures with commercial needs
  • Contribute to the development of our scanner systems, a combination of hardware and software systems in the medical device domain
Requirements
  • Deep knowledge of Risk Management within product development, adhering to ISO 14971 standards and preferably IEC 60601-1
  • Knowledge of electronics hazards and risk management of them
  • Ability to work with multiple stakeholders from different development domains
  • Hands-on approach and ability to work in teams
  • Experience with software risk management and medical device development is beneficial
About Us

3Shape is a global leader in 3D scanning and CAD/CAM solutions for dentistry. We are committed to creating award-winning solutions that change dentistry together. Our company culture is focused on diversity, equity, and inclusion, and we encourage all relevant applicants to apply.

We offer a range of benefits, including an attractive healthcare package, breakfast and lunch every day, and a good work/life balance. If you are passionate about risk management and medical device development, we encourage you to apply for this exciting opportunity.



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