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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