THAY Medical Ltd
Human Factors Engineer
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Company Description
THAT Medical Ltd is a global Human Factors Engineering consultancy based in the UK, specializing in medical products, healthcare systems, and pharmaceutical (drug delivery) devices. As an ISO 13485 certified organization, THAT Medical provides expertise in product development, device design, usability engineering, and compliance with international standards and regulatory guidance. The company supports clients with user research, design inputs, risk management activities, quality management, and project management to ensure safe, effective, and usable medical products.
THAT Medical also delivers global human factors and usability testing in line with FDA, NMPA, MHRA, and IEC/ISO 62366-1 requirements, including expert reviews and the development of user-friendly instructions and documentation. The consultancy is known for exceptional customer feedback and a collaborative approach to helping organizations achieve high usability and regulatory compliance.
Role Description
This is a full-time Human Factors Engineer role, offered on a remote basis with a work-from-home arrangement. The Human Factors Engineer will plan and conduct human factors and usability activities across the medical product development lifecycle, including user research, contextual inquiries, and formative and summative usability studies. Day-to-day tasks include performing task analyses, defining user needs and use-related risks, contributing to design inputs, and collaborating with designers, engineers, project managers, and regulatory stakeholders.
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The role involves creating usability engineering documentation, supporting compliance, and contributing to risk management files and expert reviews. The Human Factors Engineer will also help develop user interface specifications, Instructions for Use (IFUs), and other user-facing materials that align with human factors best practices and regulatory expectations.
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Qualifications
- Strong foundation in Usability and Human Factors Engineering, with experience applying these principles to medical devices, healthcare systems, or pharmaceutical (drug delivery) products.
- Proficiency in usability/human factors testing including planning and conducting studies, analyzing data, using AI tools to perform analysis, and determining resultant use-related risks.
- Knowledge of medical device design and user interface design for healthcare systems, with the ability to collaborate with teams on ergonomics, biomechanics, and material innovations.
- Experience working to medical device and usability standards and regulations (e.g., ISO 13485, IEC/ISO 62366-1, FDA human factors guidance).
- Ability to design and document usability engineering files, risk analyses, and human factors reports for regulatory submissions and internal reviews.
- Strong analytical, problem-solving, and communication skills, with the ability to present findings and recommendations to multidisciplinary teams and clients.
- Bachelor’s or Master’s degree in Human Factors, Ergonomics, Biomedical Engineering, Product Design, or a related field (or equivalent experience).
- The ability to write high-quality documentation in English.
- The ability to communicate in English at a high level.
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