Senior Human Factors Engineer – Medical Devices

Hologic, Inc.; Louisville (KY); Hybrid; USD 128,000 - 201,000; Full time

Job summary

Hologic, Inc. leads Human Factors engineering to ensure safe, intuitive medical devices from concept through commercialization.

This role focuses on usability strategy, risk management, and cross-functional collaboration while driving formative and summative studies in a hybrid Louisville, CO setting. The Lead Human Factors Engineer designs and analyzes user research, writes UI/UX specifications, and mentors staff to deliver compliant, audit-ready documentation across R&D, quality, regulatory,

Qualifications

• 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.
• 6+ years of Human Factors/Usability Engineering experience with a Master’s Degree.

Responsibilities

• 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

Skills

User-centered design

Usability engineering

Design Controls

Risk analysis

Cross-functional leadership

Regulatory knowledge

Technical writing

UI/UX specifications

Education

Bachelor’s or Master’s in Usability/Human Factors Engineering

Advanced degree preferred

Job description

Hologic, Inc. leads Human Factors engineering to ensure safe, intuitive medical devices from concept through commercialization.

This role focuses on usability strategy, risk management, and cross-functional collaboration while driving formative and summative studies in a hybrid Louisville, CO setting. The Lead Human Factors Engineer designs and analyzes user research, writes UI/UX specifications, and mentors staff to deliver compliant, audit-ready documentation across R&D, quality, regulatory,