Director of Human Factors

Position Summary:

We are seeking a Human Factors Engineer who will be responsible for ensuring that medical devices are safe, intuitive, and effective for intended users by applying human factors and usability engineering principles throughout the product lifecycle. This role plans and conducts formative and summative usability studies, develops use-related risk analyses, and ensures compliance with FDA, IEC 62366, and other applicable regulatory standards. The Human Factors Engineer collaborates closely with design, clinical, regulatory, and quality teams to identify, mitigate, and validate use-related hazards, ultimately supporting safe and effective patient and clinician experiences.

This role will work to develop and follow industry best practices defining and documenting usability formative studies, qualitative assessments, summative usability studies and preparing the Human Factors engineering usability file for reg...