Human Factors Engineer 4

Job Summary: Lead Human Factors Engineer possessing deep expertise in human factors engineering, usability engineering, and user-centered design to support and lead the development of safe, effective, and intuitive medical devices from concept through commercialization. Essential Duties and Responsibilities: The incumbent may be asked to perform other function-related activities in addition to the below mentioned as responsibilities as reasonably required by business needs. This position is responsible for performing the following tasks while driving execution of human factors work aligned with program and organizational objectives:

Expert in FDA Human Factors guidance, IEC 62366-1/-2, ANSI/AAMI HE75, and ISO 14971 use-related risk management Owns usability engineering strategy across the product lifecycle Designs and executes formative and summative usability studies, including protocols, moderator guides, and root-cause analysis of use errors Conducts user research and clinical/customer evaluations of real-world use scenarios and environments Analyzes test results and translates findings into defensible design and risk conclusions Authors and reviews UI/UX specifications, labeling, and IFUs as risk controls SME for Design Controls, Design Validation, and quality risk management within a regulated QMS; complies with all applicable FDA and ISO requirements Independently authors protocols, reports, and requirements; relied upon for thorough review of documentation, including department procedures Leads usability work cross-functionally across R&D, software, quality, regulatory, clinical, and marketing Mentors junior staff and drives results in highly complex projects

Provide technical leadership and mentoring to engineers and product development teams

Qualifications Education:

Bachelor’s or Master’s degree in Usability/Human Factors Engineering, Mechanical Engineering, Biomedical Engineering, Systems Engineering or related field. Advanced degree preferred.

8+ years of Human Factors/Usability Engineering experience, with the majority in the medical device industry, required with a Bachelor’s Degree 6+ years of Human Factors/Usability Engineering experience, with the majority in the medical device industry, required with a Master’s Degree

Expert knowledge of FDA Human Factors guidance, IEC 62366-1/-2, ANSI/AAMI HE75, and ISO 14971 Depth in Design Controls, Design Validation, and quality risk management within a regulated QMS Ability to define and own usability engineering strategy across the product lifecycle Expertise in use-related risk analysis — task analysis, critical tasks, use errors, and usability failure modes Expertise performing research on user interfaces such as physical devices, complex systems, and GUIs. Hands-on experience running formative and summative usability studies, from protocol to root-cause analysis Skilled in user research and clinical/customer evaluations of real-world use scenarios Skilled in root cause analysis Skilled in user requirement development Skilled in critical task analysis Skilled in regulatory submission support Strong analytical skills; translates test results into defensible design and risk conclusions Experience authoring UI/UX specifications, labeling, and IFUs as risk controls Excellent technical writing; produces audit-ready documentation and critically reviews procedures Proven cross-functional leadership, mentorship, and drive for results on highly complex projects

Physical Demands: The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

The employee is regularly required to sit, stand, walk, and reach with hands and arms, use hands to