ШвецияUsability Engineering Lead
3 нед. назад
ШвецияLeadHybrid
iec 62366fda human factorsusability engineeringmedical device developmentverificationvalidation
Lead usability engineering activities in medical device product development focusing on human factors and FDA compliance.
О компании
- 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.
Обязанности
- We're looking for an experienced Usability Engineer / Human Factors Engineer to drive usability engineering activities across '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.
- 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 Usability & Validation Engineers 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
Требования
- 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
Другое
- Usability engineering is core to how we build safe medical devices: it's the discipline that lets us say, with confidence, that our products aren't just functional, but safe and easy to use. At Neko we want to keep challenging how we do things so we can move faster, but never at the cost of safety or quality. As our product portfolio grows, we need a usability engineering practice that grows with it, one that keeps pace rather than becoming the bottleneck. This role is driving how usability engineering at Neko becomes a reference on integration of best practices into a fast-pacing and always innovating environment.