Sr. Human Factors Engineer

About the role

This individual contributor role will be responsible for utilizing evidence-based tools and principles to design systems and products that match the user’s needs and environment. They align research, design, and business strategies by working with project teams and business leadership to drive user-centered product development, which is proven to reduce risks, minimize development costs, and maximize market acceptance of products.

The Sr. Human Factors Engineer will play a key role in integrating human factors principles and user-centered design methodologies into the development of Becton, Dickinson and Company's medical devices and systems. This individual will ensure that products are safe, effective, and user-friendly, ultimately improving the experience for healthcare professionals and patients.

Responsibilities

• Lead and execute human factors engineering activities throughout the product development lifecycle, from concept generation to post-market surveillance.
• Conduct user research activities including contextual inquiry, ethnographic studies, and usability testing to identify user needs, preferences, and pain points.
• Develop and refine user profiles, task analyses, use scenarios, and use-related risk analyses.
• Translate user research findings into actionable design recommendations and requirements.
• Collaborate with cross-functional teams including R&D, Marketing, Regulatory, Quality, and Clinical Affairs to integrate human factors considerations into product design.
• Participate in design reviews, providing expert input on user interface, workflow, and overall usability.
• Contribute to the creation of human factors plans, reports, and other regulatory documentation (e.g., IEC 62366, FDA guidance).
• Mentor junior human factors engineers and promote a culture of user-centered design within the organization.
• Stay current with industry best practices, emerging technologies, and regulatory requirements related to human factors engineering in medical devices.

Minimum Requirements

• Education: Bachelor's degree in Human Factors Engineering, Biomedical Engineering, Industrial Design, Cognitive Science, Psychology, or a related field
• Experience: Minimum of 5 years of professional experience in human factors engineering
• Industry Experience: Minimum 5 years of experience specifically in the medical device industry (e.g., Class II or Class III devices)
• Technical Knowledge: Strong understanding of human factors principles, usability engineering, and user-centered design methodologies
• Research Methods: Demonstrated proficiency in conducting human factors research methods including usability testing, contextual inquiry, surveys, and interviews
• Regulatory Knowledge: Working familiarity with relevant medical device regulations and standards such as FDA guidance, IEC 62366, and ISO 14971
• Communication Skills: Excellent written and verbal communication skills with the ability to communicate complex technical information to diverse audiences
• Core Competencies: Strong analytical and problem-solving skills, with the ability to work both independently and collaboratively in a fast-paced environment.
• Travel Requirements: ~ 25% (about once per quarter)

Preferred Qualifications

• Advanced Education: Master's degree or Ph.D. in Human Factors Engineering, Biomedical Engineering, Cognitive Science, or related field
• Leadership Experience: Demonstrated experience leading human factors activities for complex medical devices or systems
• Software Tools: Experience with Figma
• Full Product Lifecycle Experience: Experience conducting human factors engineering activities throughout the entire product development lifecycle, from concept generation through post-market surveillance
• Advanced Research Methods: Experience with ethnographic studies and advanced contextual inquiry techniques beyond basic usability testing
• Documentation Expertise: Proven track record creating comprehensive human factors plans, reports, and regulatory documentation specifically for FDA submissions and IEC 62366 compliance
• Statistical Analysis: Proficiency with statistical analysis software such as SPSS, R, or similar tools
• Mentoring Experience: Previous experience mentoring junior human factors engineers or promoting user-centered design culture within an organization
• Risk Analysis: Specific experience developing and conducting use-related risk analyses in accordance with ISO 14971
• Cross-functional Collaboration: Demonstrated success working with R&D, Marketing, Regulatory, Quality, and Clinical Affairs teams on integrated product development
• Industry Knowledge: Active involvement in professional organizations or demonstrated commitment to staying current with emerging technologies and industry best practices in medical device human factors.