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Usability Engineering Lead

Neko Health· Engineering
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Hybrid (Stockholm)Full-timePosted 4w ago

About the role

Usability Engineer / Human Factors leadership role focusing on applying IEC 62366-1 and FDA human factors guidance within Neko Health's medical device development, driving domain growth, and ensuring safe, user-friendly products through formative/summative evaluations and integrated usability practices.

Responsibilities

  • Usability engineering in product development: lead usability activities on projects from concept through final verification
  • Domain leadership: grow the usability domain to be a reference for best practice in a fast-moving environment
  • Process and practice: improve integration of usability engineering with product development, build instructions, tooling, and training for multiple projects
  • Design feedback, early: collaborate with Product, Design, Clinical, Engineering, and others to integrate feedback early for safe use
  • Formative and summative evaluation: plan, run, and document usability evaluations per IEC 62366-1 and FDA guidance, leveraging in-house clinical access
  • Design validation: oversee validation of UI-related user requirements and verification of use-related risk controls to avoid bottlenecks

Qualifications

  • 6+ years of experience in usability engineering or human factors for regulated medical devices
  • Hands-on IEC 62366-1 usability engineering experience, including planning and conducting formative/summative evaluations and use-related risk analysis
  • FDA human factors experience with demonstrated practices meeting FDA guidance
  • Experience with regulated medical devices and evidence for ISO 13485 and EU MDR design history/file
  • Built or scaled a usability engineering practice with methods, tooling, or teams
  • Comfortable with hardware-software medical devices (SaMD) ensuring cohesive usability across hardware/software

Skills

Required:Usability EngineeringUse-related risk analysisDomain leadershipCross-functional collaborationRegulatory knowledge (ISO 13485, EU MDR)
Last updated Sep 25, 2026. Interested? Apply on the company site.
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