BD

Staff Human Factors, Design Validation Engineer

BD

full-time

Posted on:

Location Type: Hybrid

Location: Franklin Lakes • California • New Jersey • United States

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Salary

💰 $130,400 - $215,200 per year

Job Level

Lead

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
human factors engineeringdesign validationusability testinguser researchdata analysisrisk managementcontextual inquiryethnographic studiesformative usability testingsummative usability testing
Soft Skills
analytical skillsproblem-solving skillscritical thinkingcommunication skillsmentorshipcollaborationindependencepresentation skills