Senior Human Factors Engineer

As a Human Factors Engineer, you will play a vital role in elevating the user experience and ensuring patient safety for our cutting-edge diagnostic products. By actively planning and conducting human factors research – from critical usability studies to thorough user risk analyses – you'll uncover key insights. Lead Human Factors Engineering (HFE) activities throughout the product development lifecycle, ensuring the safe and effective use of medical devices through application of usability engineering and risk management principles. Develop and execute HFE strategies, plans, and deliverables in compliance with FDA Human Factors Guidance, IEC 62366-1, ISO 14971, and internal design control processes. Plan, conduct, and report user research, formative evaluations, and summative usability validation studies to identify and mitigate use-related risks and support regulatory submissions. Author and maintain key HFE deliverables, including use specifications, task analyses, critical task assessments, use-related risk analyses, and usability engineering files. Partner with cross-functional teams to integrate human factors into design inputs, requirements, risk management activities, verification efforts, and product development decisions while providing technical leadership and mentorship. Bachelor's degree in Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Ergonomics, Psychology, Cognitive Science, Systems Engineering, or a related technical discipline. 5+ years of Human Factors Engineering experience in a regulated industry, including medical device or combination product development. Demonstrated experience applying human factors engineering principles within a design controls environment and using risk management methodologies aligned with ISO 14971. Experience planning, conducting, and documenting formative and summative usability studies in accordance with FDA Human Factors Guidance and IEC 62366-1. Strong technical writing, communication, and collaboration skills, with the ability to work independently and influence cross-functional teams in a matrixed environment. Authoring human factors documentation supporting FDA, EU MDR, Health Canada, or other global regulatory submissions. Supporting the development of complex medical technologies, including infusion systems, diagnostics, patient monitoring systems, or Software as a Medical Device (SaMD). Applying systems engineering, FMEA, hazard analysis, fault analysis, or other risk assessment methodologies to identify and mitigate use-related risks. Learn about the Danaher Business System which makes everything possible. It would be a plus if you also possess previous experience in.