An experienced Human Factors Engineer with seven years of experience in the medical device sector, specialising in the application of human factors engineering across the full product development lifecycle for a Class II haemodialysis system. The candidate has deep expertise in FDA Human Factors Guidance (2016), IEC 62366‑1/‑2 and ISO 14971, and is highly effective in translating human factors insights into robust, regulator‑ready design decisions. They are a confident cross‑functional leader, regularly influencing engineering, clinical, quality and regulatory stakeholders through risk‑based usability analysis, human error investigation, and safety case contributions.

The candidate has successfully led and delivered multiple FDA 510(k) submissions, including complex home‑use and clinical systems, all achieving FDA clearance. Their background includes building and maturing human factors capability within an organisation, leading global formative and validation studies, managing internal engineers and external consultants, and acting as the Human Factors lead in regulatory interactions. The candidate is now looking for their next challenge and is open to hybrid and remote working.

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