Principal Usability Engineer

Job Description

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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