Usability Engineer / Human Factors Engineer (Medical Devices)

Location: Stockholm, Sweden; hybrid

Company

hirify.global develops preventative healthcare through non-invasive medical technology, direct clinical care, and data-driven health insights.

What you will do

• Lead usability engineering activities across medical device product development from early concept through final verification.
• Develop and scale usability engineering practices, including methods, processes, tooling, instructions, and training.
• Collaborate with Usability and Validation Engineers to provide design feedback early and integrate safety into product design.
• Plan, conduct, and document formative and summative usability evaluations using IEC 62366-1 and FDA human factors guidance.
• Oversee validation of UI-related user requirements and verification of use-related risk controls.
• Help establish the usability engineering domain as a best-practice reference across a fast-growing product portfolio.

Requirements

• 6+ years of experience in usability engineering or human factors for regulated medical devices.
• Hands-on experience with IEC 62366-1, including formative and summative evaluations and use-related risk analysis.
• Practical experience implementing FDA human factors guidance.
• Experience with regulated medical devices and design validation evidence in technical files or design history files under ISO 13485 and EU MDR.
• Experience building or scaling a usability engineering practice through methods, tooling, or team development.
• Experience with both hardware-software medical devices and software-only devices, including SaMD.

Nice to have

• Experience in an early-stage or fast-growing company.
• Experience establishing a new practice or domain.
• ISO 14971 risk management experience involving use errors and product risk.

Culture & Benefits

• Work in a mission-driven environment focused on preventative healthcare and earlier intervention.
• Help improve usability practices while maintaining medical device safety and quality.
• Collaborate with clinical personnel directly through vertically integrated, in-house access.
• Operate in a fast-moving and continuously innovating product development environment.