Staff Human Factors, Design Validation Engineer

Role Overview

• 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

• Bachelor's degree in Human Factors Engineering, Biomedical Engineering, Industrial Design, Cognitive Science, or a related field.
• Master's degree preferred.
• 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