Staff Human Factors & Design Validation Engineer

BD is one of the largest global medical technology companies in the world. They are seeking a Staff Engineer to lead Human Factors Engineering activities and design validation for medical devices, ensuring user-centered design, safety, and regulatory compliance.

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

Requirements:

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