About this role

Conduct early-stage generative research to discover user needs, contexts of use, and unmet needs
Execute user characterization studies to explore the capabilities, limitations, and variability of intended user populations
Perform functional task analysis, use-related hazard analysis, and known use problems analysis
Apply good study design to enable iterative UI design leveraging a range of research and testing methods
Conduct use error analysis and root cause analysis
Translate study results into user needs, design recommendations, and UI specifications
Develop study protocols and execute summative validation studies
Support regulatory submissions and health authority interactions

Bachelor's degree in human factors, psychology, biomedical engineering, or related field
2.5 to 5 years applying human factors engineering to medical devices or combination products
Health Authority & Standards knowledge of relevant FDA HF Guidance documents, IEC 62366-1:2015+A1:2020, ISO 14971:2019, ISO 13485, EMA guidelines
Strong cross-functional collaboration and communication skills (written and spoken English)
Willingness to travel to study sites (up to 20%)

Human Factors and Usability Engineer

Key skills