What are the responsibilities and job description for the Staff Human Factors, Design Validation Engineer position at UXR Hunt?
Job Description: Lead and execute human factors engineering activities throughout the product development lifecycle, from concept to post-market, for various medical devices.
Conduct user research, including contextual inquiry, ethnographic studies, and formative usability testing, to identify user needs, mental models, and pain points.
Translate user research findings into clear and actionable design requirements and specifications.
Develop and execute comprehensive design validation plans and protocols, including summative usability testing, to demonstrate the safety and effectiveness of medical devices for intended users and use environments.
Analyze and interpret data from usability studies, identifying critical user interface issues, risks, and opportunities for improvement.
Prepare detailed human factors reports, design validation reports, and other technical documentation for internal stakeholders and regulatory submissions (e.g., FDA, EU MDR).
Collaborate cross-functionally with R&D, Marketing, Quality, Regulatory Affairs, and Clinical teams to integrate HFE principles into product design and development.
Provide expert guidance and mentorship to junior engineers and project teams on human factors best practices and regulatory requirements.
Participate in risk management activities, including use-related risk analysis, and contribute to the development of mitigation strategies.
Stay current with industry best practices, regulatory guidance (e.g., IEC 62366-1, AAMI HE75), and emerging technologies in human factors and medical device development.
Requirements: Bachelors degree in Human Factors Engineering, Biomedical Engineering, Industrial Design, Cognitive Science, or a related field.
5 years of experience in human factors engineering and design validation within the medical device industry.
Strong understanding of medical device regulations and standards related to human factors (e.g., FDA Human Factors Guidance, IEC 62366-1, AAMI HE75).
Proven experience in planning, executing, and reporting on formative and summative usability studies.
Demonstrated ability to translate user research into design requirements and specifications.
Excellent analytical, problem-solving, and critical thinking skills.
Strong written and verbal communication skills, with the ability to effectively present technical information to diverse audiences.
Proficiency with usability testing tools and software.
Ability to work independently and as part of a cross-functional team in a fast-paced environment.
Benefits: Annual Bonus
Health and Well-being Benefits
Medical coverage
Health Savings Accounts
Flexible Spending Accounts
Dental coverage
Vision coverage
Hospital Care Insurance
Critical Illness Insurance
Accidental Injury Insurance
Life and AD&D insurance
Short-term disability coverage
Long-term disability insurance
Long-term care with life insurance
Other Well-being Resources
Anxiety management program
Wellness incentives
Sleep improvement program
Diabetes management program
Virtual physical therapy
Emotional/mental health support programs
Weight management programs
Gastrointestinal health program
Substance use management program
Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit
Retirement and Financial Well-being
BD 401(k) Plan
BD Deferred Compensation and Restoration Plan
529 College Savings Plan
Financial counseling
Baxter Credit Union (BCU)
Daily Pay
College financial aid and application guidance
Life Balance Programs
Paid time off (PTO), including all required State leaves
Educational assistance/tuition reimbursement
MetLife Legal Plan
Group auto and home insurance
Pet insurance
Commuter benefits
Discounts on products and services
Academic Achievement Scholarship
Service Recognition Awards
Employer matching donation
Workplace accommodations
Other Life Balance Programs
Adoption assistance
Backup day care and eldercare
Support for neurodivergent adults, children, and caregivers
Caregiving assistance for elderly and special needs individuals
Employee Assistance Program (EAP)
Paid Parental Leave
Support for fertility, birthing, postpartum, and age-related hormonal changes
Leave Programs
Bereavement leaves
Military leave
Personal leave
Family and Medical Leave (FML)
Jury and Witness Duty Leave
Conduct user research, including contextual inquiry, ethnographic studies, and formative usability testing, to identify user needs, mental models, and pain points.
Translate user research findings into clear and actionable design requirements and specifications.
Develop and execute comprehensive design validation plans and protocols, including summative usability testing, to demonstrate the safety and effectiveness of medical devices for intended users and use environments.
Analyze and interpret data from usability studies, identifying critical user interface issues, risks, and opportunities for improvement.
Prepare detailed human factors reports, design validation reports, and other technical documentation for internal stakeholders and regulatory submissions (e.g., FDA, EU MDR).
Collaborate cross-functionally with R&D, Marketing, Quality, Regulatory Affairs, and Clinical teams to integrate HFE principles into product design and development.
Provide expert guidance and mentorship to junior engineers and project teams on human factors best practices and regulatory requirements.
Participate in risk management activities, including use-related risk analysis, and contribute to the development of mitigation strategies.
Stay current with industry best practices, regulatory guidance (e.g., IEC 62366-1, AAMI HE75), and emerging technologies in human factors and medical device development.
Requirements: Bachelors degree in Human Factors Engineering, Biomedical Engineering, Industrial Design, Cognitive Science, or a related field.
5 years of experience in human factors engineering and design validation within the medical device industry.
Strong understanding of medical device regulations and standards related to human factors (e.g., FDA Human Factors Guidance, IEC 62366-1, AAMI HE75).
Proven experience in planning, executing, and reporting on formative and summative usability studies.
Demonstrated ability to translate user research into design requirements and specifications.
Excellent analytical, problem-solving, and critical thinking skills.
Strong written and verbal communication skills, with the ability to effectively present technical information to diverse audiences.
Proficiency with usability testing tools and software.
Ability to work independently and as part of a cross-functional team in a fast-paced environment.
Benefits: Annual Bonus
Health and Well-being Benefits
Medical coverage
Health Savings Accounts
Flexible Spending Accounts
Dental coverage
Vision coverage
Hospital Care Insurance
Critical Illness Insurance
Accidental Injury Insurance
Life and AD&D insurance
Short-term disability coverage
Long-term disability insurance
Long-term care with life insurance
Other Well-being Resources
Anxiety management program
Wellness incentives
Sleep improvement program
Diabetes management program
Virtual physical therapy
Emotional/mental health support programs
Weight management programs
Gastrointestinal health program
Substance use management program
Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit
Retirement and Financial Well-being
BD 401(k) Plan
BD Deferred Compensation and Restoration Plan
529 College Savings Plan
Financial counseling
Baxter Credit Union (BCU)
Daily Pay
College financial aid and application guidance
Life Balance Programs
Paid time off (PTO), including all required State leaves
Educational assistance/tuition reimbursement
MetLife Legal Plan
Group auto and home insurance
Pet insurance
Commuter benefits
Discounts on products and services
Academic Achievement Scholarship
Service Recognition Awards
Employer matching donation
Workplace accommodations
Other Life Balance Programs
Adoption assistance
Backup day care and eldercare
Support for neurodivergent adults, children, and caregivers
Caregiving assistance for elderly and special needs individuals
Employee Assistance Program (EAP)
Paid Parental Leave
Support for fertility, birthing, postpartum, and age-related hormonal changes
Leave Programs
Bereavement leaves
Military leave
Personal leave
Family and Medical Leave (FML)
Jury and Witness Duty Leave