User Experience Specialist in Medical Devices

4 days ago


Hörby Kommun, Sweden Coloplast Full time

At Atos Medical, we design products that help people breathe, speak, and live better after a life-changing neck stoma operation. We are now seeking a User Experience Specialist in Medical Devices to take ownership of our usability engineering/human factor processes.

The Role

You will be a key player in keeping users at the center of the development process and ensuring our medical devices meet regulatory requirements. As a Senior User Experience Specialist in R&D, you'll drive the usability engineering process collaborating with cross-functional teams like engineering, marketing, clinical, and regulatory affairs.

Key Responsibilities**

  • Closely work with stakeholders across commercial, marketing, R&D, risk management, and more.
  • Conduct usability testing, analyze results, and report findings.
  • Effectively communicate the user's perspective during the development process and train the organization in usability processes and methods.
  • Lead the usability engineering process, ensuring compliance to ISO 62366 and other regulatory standards while continuously improving processes and supporting colleagues.
  • Manage usability engineering files, test protocols, reports, and analyses.

About You

We're looking for an experienced usability expert who thrives on taking ownership, drives processes, and enjoys working in cross-functional teams. Your background should include:

  • A degree in engineering, psychology, human factors, or a related field.
  • Solid understanding of ISO 62366 and related standards (e.g., FDA HF guidance, ANSI/AAMI HE75, ISO 14971).
  • Hands-on experience in usability testing and human-centered design.
  • Strong collaboration and project management skills.
  • Excellent written and verbal communication skills.


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