Medical Device Usability Expert

5 days ago


Hörby Kommun, Sweden Coloplast Full time

**Job Overview**

We are seeking a highly skilled Medical Device Usability Expert to join our R&D team at Atos Medical. As a key player in the development process, you will be responsible for ensuring that our medical devices meet regulatory requirements while being user-friendly and impactful.

**Responsibilities**

  • Collaborate with stakeholders across commercial, marketing, R&D, risk management, and more to drive the usability engineering process.
  • Plan and execute usability tests, including interviewing end users, analyzing results, and reporting.
  • Communicate and present the user's perspective during the development process, training 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.
  • Document usability engineering files, test protocols, reports, and analyses.

About You

We are looking for an experienced usability expert who thrives on taking ownership, drives processes, and enjoys working in cross-functional teams. Key qualifications 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 planning and moderating usability tests, including creating protocols, moderator scripts, and reports.
  • Strong skills in stakeholder collaboration and project management.
  • Excellent communication skills, both written and verbal with internal and external stakeholders.


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