Principal Usability Engineer

24 Days Old

Halian is proud to partner with a pioneering medical device company based in Oxfordshire offering hybrid working, looking for a Principal Usability Engineerto take ownership of usability engineering across the full product development lifecycle, ensuring innovative implantable and surgical systems are safe, effective, and intuitive for clinical use.
This is a high-impact role where youll champion user-centered design and play a key part in shaping the future of advanced medical technologies. Youll work cross-functionally to embed human factors thinking into every stage of development, ensuring compliance with global standards and regulatory frameworks including ISO 62366, FDA, EU MDR, and UK regulations.
Your Responsibilities
Define and lead the human factors strategy. Plan and execute formative and summative usability studies, including cadaver labs and clinical simulations. Translate user needs into design inputs and risk management documentation. Develop usability engineering files and documentation for global regulatory submissions. Collaborate with design, clinical, engineering, regulatory, and quality teams to integrate usability throughout development. Own use-related risk analysis and ensure alignment with broader risk management processes. Manage external partners conducting usability research, ensuring high-quality outputs. Build deep product knowledge to support usability evaluations and continuous system testing. Maintain traceability across user needs, usability risks, design controls, and verification evidence. Present usability findings to internal and external stakeholders and represent human factors in audits and design reviews. Contribute to innovation and IP development through user-driven insights. Stay current with industry trends, best practices, and evolving regulatory expectations. Travel as needed to support studies and collaborate with global teams.
Your Profile
Essential: Degree (Bachelors or Masters) in Human Factors Engineering, Ergonomics, Biomedical Engineering, or related field. Extensive experience in human factors engineering within the medical device sector. Proven track record working with surgical or implantable devices and conducting cadaver lab studies. Strong understanding of FDA, EU, and UK usability regulations and ISO 62366. Experience producing usability documentation for regulatory submissions. Comfortable working in multidisciplinary environments with clinical involvement.
Desirable: Experience with neuromodulation or urology-related devices. Familiarity with software UI/UX development and system-level evaluation. Knowledge of international regulatory bodies and clinical trial interfaces. Certification in human factors or usability engineering.
This position offers the chance to make a real impact in the medical device industry, working on life-changing technologies in a dynamic, collaborative environment. If youre a strategic thinker with a passion for usability and innovation, please apply
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Location:
London
Salary:
not provided
Job Type:
FullTime
Category:
IT

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