Usability Engineering Lead

Neko Health

. Lead usability engineering activities across Neko Health's medical device product development projects from early concept through final verification .

Posted 9/23/2026full-timeStockholm • SwedenSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in usability engineering for regulated medical devices, including hands-on experience with IEC 62366-1 and FDA human factors guidance. Capable of leading usability evaluations, building usability practices, and ensuring alignment with product development.

Highest-signal resume keywords

Usability Engineering ExpertiseIEC 62366-1 ComplianceFDA Human Factors ExperienceISO 13485 KnowledgeRisk Management (ISO 14971)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Usability Evaluation PlanningFormative EvaluationsSummative EvaluationsUse-Related Risk AnalysisDesign Validation Evidence

Tools & Technologies

Usability ToolingTraining Development

Industry Keywords

Regulated Medical DevicesVerification & ValidationHuman Factors GuidanceTechnical FileDesign History FileEU MDR

About the role

Key responsibilities & impact

Lead usability engineering activities across Neko Health's medical device product development projects from early concept through final verification
Grow the usability engineering domain's capability and practice within the Verification & Validation team
Continuously improve the integration of usability engineering with product development
Build instructions, tooling, and training to support multiple development projects
Collaborate with Usability & Validation Engineers to provide early design feedback
Plan, run, and document formative and summative usability evaluations according to IEC 62366-1 and FDA human factors guidance
Oversee validation of UI-related user requirements and verification of use-related risk controls
Ensure medical devices are safe and easy to use while keeping usability engineering aligned with product development

Requirements

What you’ll need

6+ years of experience in usability engineering or human factors for regulated medical devices
Hands-on expertise with IEC 62366-1 usability engineering, including planning and conducting formative and summative evaluations on medical devices and performing use-related risk analysis
FDA human factors experience, implementing usability engineering practices that meet FDA guidance with concrete examples
Experience with regulated medical devices and understanding how usability and design validation evidence fit into a technical file or design history file under ISO 13485 and EU MDR
Experience building or scaling a usability engineering practice by developing methods, tooling, or teams
Comfortable working with both hardware and software, including hardware-software combinations and software-only devices (SaMD)
Experience in an early-stage or fast-growing company (nice to have)
Experience standing up a new practice or domain (nice to have)
ISO 14971 risk management experience, specifically where use error and product risk intersect (nice to have)

Benefits

Comp & perks

No benefits or compensation extras are specified in the posting