SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
Neko Health is redefining preventative care through data-driven, non-invasive health assessments that deliver personalized, actionable insights before symptoms appear. The company combines proprietary technology with direct clinical care to make prevention accessible at scale.
You will lead usability engineering activities across Neko's medical device product development and grow this domain within the Verification & Validation team. This is a hands-on leadership role that bridges product development and regulatory compliance.
Key responsibilities:
- Lead usability engineering activities on product development projects from early concept through final verification, applying IEC 62366-1 and FDA human factors guidance
- Build and scale the usability engineering practice by developing methods, tooling, training, and team capability to support multiple concurrent projects
- Collaborate with Usability & Validation Engineers to integrate design feedback as early as possible in development, ensuring safety is designed in rather than tested later
- Plan, run, and document formative and summative usability evaluations following regulatory standards, leveraging Neko's in-house clinical access
- Oversee validation of UI-related user requirements and verification of use-related risk controls, ensuring processes remain efficient and don't become development bottlenecks
- Continuously improve how usability engineering integrates with product development, building processes that scale with the company
- Work with both hardware and software medical devices, including hardware-software combinations and software-only devices (SaMD)
You'll be working in a fast-moving, 10x-thinking environment where your work directly impacts patient safety and health outcomes.
REQUIREMENTS
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 with concrete examples of implementing usability engineering practices that meet FDA guidance
- Experience with regulated medical devices and understanding how usability and design validation evidence fit into technical files or design history files under ISO 13485 and EU MDR
- Demonstrated experience building or scaling a usability engineering practice by developing methods, tooling, or teams beyond 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)
Nice to have:
- Experience in early-stage or fast-growing companies 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
