Neko Health
Usability Engineering Lead
Stockholm, Remote. Posted a month ago
The role
You will drive usability engineering activities across product development and lead the domain within the Verification & Validation team. You will plan and document usability evaluations to ensure medical devices are safe to use.
What you will do
- Lead usability engineering activities from early concept through final verification
- Grow the domain capability and practice to become a reference for best practice
- Improve how usability engineering integrates with product development
- Build instructions, tooling, and training to support multiple development projects
- Collaborate with Product, Design, Clinical, and Engineering to integrate design feedback early
- Plan, run, and document usability evaluations following IEC 62366-1 and FDA human factors guidance
- Oversee validation of UI-related user requirements
- Oversee verification of use-related risk controls
Required qualifications
- 6+ years of experience in usability engineering or human factors for regulated medical devices
- Hands-on expertise with IEC 62366-1 usability engineering
- Experience planning and conducting formative and summative evaluations on medical devices
- Experience performing use-related risk analysis
- FDA human factors experience implementing usability engineering practices that meet FDA guidance
- Experience with regulated medical devices
- 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
- Experience with medical devices that include hardware-software combinations and software-only devices (SaMD)
Nice to have
- Experience in an early-stage or fast-growing company
- Experience standing up a new practice or domain
- ISO 14971 risk management experience, specifically where use error and product risk intersect
About the company
Neko is redefining what prevention means by making data-driven, preventative care accessible through proprietary technology and direct clinical care.