Job Description Summary

The HF/UX (Human Factors/User Experience) Team within the Medication Delivery Solutions (MDS) business unit is seeking a Human Factors & Design Validation Engineer to lead and execute activities across product families. This individual contributor role will be responsible for applying evidence-based human factors principles to reduce use-related risks, ensure regulatory compliance, and support product safety and effectiveness.

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Job Summary
We are seeking a highly skilled Staff Human Factors & Design Validation Engineer to lead Human Factors Engineering (HFE) activities and design validation for medical devices, ensuring user-centered design, safety, and regulatory compliance.

Job Responsibilities

• 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.

Job Qualifications

• 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.

At BD, we are committed to supporting our associates’ well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role:

• Annual Bonus

Health and Well-being Benefits

• Medical coverage
• Health Savings Accounts
• Flexible Spending Accounts
• Dental coverage
• Vision coverage
• Hospital Care Insurance<