Human Factors Engineer

PURPOSE & SCOPE

The Human Factors Engineer leads usability engineering activities for the Company's medical electronic device products, including connected/wearable devices, companion mobile applications (SaMD), and desktop/handheld devices. This role ensures that user interfaces and use-related workflows are designed, evaluated, and validated to minimize use error and use-related risk, in accordance with IEC 62366-1 and applicable FDA, EU MDR, and NMPA human factors expectations.

RESPONSIBLITIES

. Develop and maintain the Human Factors Engineering (HFE)/Usability Engineering File in accordance with IEC 62366-1, including use specification, user interface specification, and use-related risk analysis.

. Plan and conduct formative usability evaluations throughout the design process to identify and mitigate use-related risks early in development.

. Plan, conduct, and report summative (validation) usability studies in accordance with IEC 62366-1 and FDA Human Factors guidance to support regulatory submissions.

. Identify critical tasks and use scenarios, and support use-related risk analysis in collaboration with the Systems Engineering and Risk Management teams (ISO 14971).

. Collaborate with UX/UI designers, systems engineers, and software/firmware engineers to translate human factors findings into user interface and workflow design requirements for the mobile application, reader device, and wearable sensor/transmitter.

. Develop and execute usability test protocols, recruit and screen representative users, and moderate usability sessions (in person or remote).

. Analyze and document use errors, close calls, and user feedback drive root cause analysis and design mitigations.

. Prepare human factors documentation to support regulatory submissions (FDA 510(k)/De Novo, EU MDR technical file, NMPA registration).

. Support labeling, instructions for use (IFU), and training material development from a usability perspective.

. Participate in design reviews and risk management activities, providing human factors input on design changes.

. Stay current with regulatory and industry expectations for human factors engineering in electronic and software medical devices (FDA, EU MDR, NMPA).

QUALIFICATIONS & EXPERIENCE

. Bachelor's or Master's Degree in Human Factors Engineering, Industrial/Systems Engineering, Cognitive/Experimental Psychology, Biomedical Engineering, or a related discipline.

. Minimum 3+ years of human factors/usability engineering experience, with demonstrated experience within the medical device industry.

. Demonstrated experience planning and executing formative and summative usability studies for connected/wearable or software-driven medical devices (SaMD).

. Strong working knowledge of IEC62366-1 (Application of Usability Engineering to Medical Devices), with familiarity with IEC 62366-2 (guidance).

. Familiarity with FDA Human Factors and Usability Engineering guidance and EU MDR human factors/usability expectations.

. Experience developing use-related risk analysis in coordination with ISO 14971 risk management processes.

. Experience moderating usability studies (in-person and/or remote) and analyzing qualitative/quantitative usability data.

. Bilingual proficiency in English and Chinese (spoken and written), with the ability to communicate and produce technical documentation in both languages - English to support FDA and EU MDR regulatory submissions, and Chinese to support NMPA registration submissions for the Chinese market.