Human Factors Engineer 4

Hologic•Louisville, KY

2d•Hybrid

About The Position

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. 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.

Requirements

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

Nice To Haves

Advanced degree preferred.

Responsibilities

Performing human factors work aligned with program and organizational objectives
Designing and executing formative and summative usability studies, including protocols, moderator guides, and root-cause analysis of use errors
Conducting user research and clinical/customer evaluations of real-world use scenarios and environments
Analyzing test results and translating findings into defensible design and risk conclusions
Authoring and reviewing UI/UX specifications, labeling, and IFUs as risk controls
Serving as SME for Design Controls, Design Validation, and quality risk management within a regulated QMS
Complying with all applicable FDA and ISO requirements
Independently authoring protocols, reports, and requirements
Reviewing documentation, including department procedures
Leading usability work cross-functionally across R&D, software, quality, regulatory, clinical, and marketing
Providing technical leadership and mentoring to engineers and product development teams
Driving results in highly complex projects