Human Factors Engineer 4

Hologic, Inc.; Louisville (CO); On-site; USD 128,000 - 201,000; Full time

Job summary

Hologic, Inc. is seeking a Lead Human Factors Engineer to guide usability engineering across the device lifecycle, ensuring safe, intuitive medical devices from concept to commercialization.

You will design and execute formative/summative studies, conduct user research, and translate findings into risk-informed design decisions while mentoring a cross-functional team.

Qualifications

• 8+ years of Human Factors/Usability Engineering experience, majority in medical device industry, with Bachelor’s Degree
• 6+ years of Human Factors/Usability Engineering experience, majority in medical device industry, with 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 and moderator guides
• 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
• Independently authors protocols, reports, and requirements; reviews documentation
• Leads usability work cross-functionally across R&D, software, quality, regulatory, clinical, and marketing
• Mentors junior staff and drives results on highly complex projects

Skills

FDA guidance

Design Controls

Risk management

Use-related risk analysis

Root cause analysis

UI/UX specifications

Cross-functional leadership

Education

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

Job description

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.

• Expert in FDA Human Factors guidance,IEC 62366-1/-2,ANSI/AAMI HE75, andISO 14971use-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

Supervisory Responsibilities:

• 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.

Experience:

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

Skills:

• Expert knowledge of FDA Human Factors guidance,IEC 62366-1/-2,ANSI/AAMI HE75, andISO 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 finger, handle, feel, and be able to talk and hear.
• Specific vision abilities required by this job include close vision, color vision, and the ability to adjust focus.
• Ability to lift or move up to 25 pounds.
• Ability to work flexible hours.

Work Environment:

This position follows a hybrid work model, requiring the employee to beon-site at our Louisville, CO location at least 4 days per week, with the flexibility to choose which day to work remote.

Travel:

• Ability to travel up to 10% as needed.

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.

The annualized base salary range for this role is$128,200 - $200,500and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

As part of our commitment to a fair and accurate evaluation of each candidate's qualifications, we require all applicants to refrain from using AI tools, such as generative AI or automated writing assistance, during any stage of the interview process. Responses influenced by AI may result in disqualification. We appreciate your understanding and cooperation in ensuring a transparent and equitable selection process.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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