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Ux/usability Engineering Specialist

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Life Science Talent

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Location:
Denmark , Farum

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Category:
IT - Software Development

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

We are looking for a UX/Usability Engineering Specialist to strengthen our R&D organization and ensure that usability engineering and risk management are effectively integrated into the development of our next generation of medical devices. This is a newly established role within R&D, offering a unique opportunity to shape and advance how usability engineering and human factors are applied across our development activities. You will report to the CTO, Christian C. Bürger, and play an important role in scoping R&D regulatory strategy and decision making. You will act as the internal subject-matter expert for usability engineering, working closely with Regulatory Affairs, Quality, and cross-functional teams across R&D, Clinical, Marketing, and Sales. Your role will be to translate regulatory requirements and user insights into practical guidance that supports safe, intuitive, and compliant products.

Job Responsibility:

  • Serve as the internal specialist for usability engineering and human factors
  • Ensure alignment with relevant standards and regulations, including IEC 62366-1, ISO 14971, IEC 62304, IEC 60601-1-6, ISO 13485, EU MDR, and FDA 21 CFR Part 820
  • Guide R&D teams in applying usability engineering and risk management in development projects
  • Plan, support, and document usability activities, including formative and summative usability evaluations
  • Collaborate with Regulatory Affairs, Quality, Clinical, Marketing, and Product teams
  • Integrate usability engineering into design control and risk management processes
  • Translate standards and regulatory requirements into clear, actionable guidance
  • Drive improving processes, templates, and best practices within usability engineering

Requirements:

  • A relevant academic background such as Mechanical Engineering (Design and Innovation), Industrial Design, Human Factors, or similar
  • Experience from the medical device industry, ideally with exposure to Regulatory Affairs or Design Control
  • Strong knowledge of usability engineering and risk management in regulated environments
  • Experience applying relevant standards and regulations, including: IEC 62366-1, ISO 14971, IEC 62304, IEC 60601-1-6, ISO 13485, EU MDR, FDA 21 CFR Part 820
  • Familiarity with guidance such as IEC/TR 62366-2, FDA Human Factors guidance, and ANSI/AAMI HE75
  • Strong communication and stakeholder management skills
  • Fluency in English (Danish is a plus)
  • Analytical and structured
  • Detail-oriented but pragmatic in a fast-moving development environment
  • Motivated by driving continuous improvement and process development
  • Curious and eager to learn
  • A team player who thrives in cross-functional settings
What we offer:
  • Flex hours with an average of 37-hour work week
  • Attractive benefits including pension, lunch scheme, and health insurance
  • An informal culture and great colleagues

Additional Information:

Job Posted:
March 14, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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