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. 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: Approximately 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