MISSION
Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before it's ever at risk. Our mission: make data-driven, preventative care accessible to more people, before symptoms appear.
In a single, non-invasive visit under an hour, proprietary technology and direct clinical care combine to deliver personalised, actionable insights. It's a team that thinks in 10x, not 10%. Every role here plays a part in building a world where prevention is the norm, and where your work genuinely helps people live longer, healthier lives.
ABOUT THE ROLE
We're looking for an experienced Usability Engineer / Human Factors Engineer to drive usability engineering activities across Neko Health's product development, and to lead the development of this domain within the Verification & Validation team.
You'll bring hands-on experience applying IEC 62366-1 to medical device product development, alongside proven experience implementing usability practices that meet FDA human factors guidance. You'll work closely with the Usability & Validation Engineers on the team to get design feedback into projects as early as possible, so that Neko's medical devices are safe to use.
WHAT YOU'LL DO
- Usability engineering in product development: join product development projects as part of the usability engineering practice, leading usability engineering activities on each project from early concept through final verification
- Domain leadership: grow the domain's capability and practice until it becomes a reference for best practice in a fast-moving environment, constantly questioning processes without losing sight of purpose and user impact
- Process and practice: continuously improve how usability engineering integrates with product development, enabling it to run alongside development. Build instructions, tooling, and training to efficiently support multiple development projects
- Design feedback, early: collaborate with Product, Design, Clinical, Engineering ,and other disciplines to integrate design feedback in projects as early as possible, ensuring safety in use is designed in rather than tested later
- Formative and summative evaluation: plan, run, and document usability evaluations following IEC 62366-1 and FDA human factors guidance, leveraging Neko's vertical integration for direct, in-house access to clinical personnel
- Design validation: oversee validation of UI-related user requirements and verification of use-related risk controls, ensuring both processes are efficient enough to keep up with development without becoming bottlenecks
ABOUT YOU
Must-have:
- 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, understanding how usability and design validation evidence fit into a technical file or design history file under ISO 13485 and EU MDR
- Built or scaled a usability engineering practice by developing methods, tooling, or teams, beyond just executing individual studies
- Comfortable working with both hardware and software; experience with medical devices that include hardware-software combinations as well as software-only devices (SaMD), ensuring cohesive usability engineering across both
Nice to have:
- Experience in an early-stage or fast-growing company, where process, team structure and priorities shift as the company scales
- Experience standing up a new practice or domain
- ISO 14971 risk management experience, specifically where use error and product risk intersect
WHY THIS ROLE MATTERS
Usability engineering is core to how we build safe medical devices: it's the discipline that lets us say, with…