Senior Human Factors Engineer

• Lead and execute human factors engineering activities throughout the product development lifecycle, from concept generation to post-market surveillance
• Conduct contextual inquiry, ethnographic studies, usability testing, surveys, and interviews 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 R&D, Marketing, Regulatory, Quality, and Clinical Affairs teams
• Participate in design reviews and provide expert input on user interface, workflow, and overall usability
• Create human factors plans, reports, and regulatory documentation, including IEC 62366 and FDA guidance documentation
• Mentor junior human factors engineers and promote user-centered design
• Stay current with industry best practices, emerging technologies, and regulatory requirements

• Bachelor's degree in Human Factors Engineering, Biomedical Engineering, Industrial Design, Cognitive Science, Psychology, or a related field
• Minimum of 5 years of professional experience in human factors engineering
• Minimum of 5 years of experience specifically in the medical device industry, such as Class II or Class III devices
• Strong understanding of human factors principles, usability engineering, and user-centered design methodologies
• Proficiency in usability testing, contextual inquiry, surveys, and interviews
• Working familiarity with FDA guidance, IEC 62366, and ISO 14971
• Excellent written and verbal communication skills
• Strong analytical and problem-solving skills
• Ability to work independently and collaboratively in a fast-paced environment
• Approximately 25% travel, about once per quarter

Demonstrates expertise in human factors engineering, usability testing, and user-centered design methodologies within the medical device industry. Proficient in regulatory documentation and collaboration with cross-functional teams to enhance product usability and compliance.

• Human Factors Engineering
• Usability Testing
• FDA Guidance
• IEC 62366
• User-Centered Design

• Contextual Inquiry
• Ethnographic Studies
• Surveys
• Interviews
• Task Analyses
• Use Scenarios
• Use-Related Risk Analyses
• Design Recommendations
• Regulatory Documentation
• Usability Engineering

• Excellent Communication Skills
• Analytical Skills
• Problem-Solving Skills
• Collaboration
• Mentoring

• Medical Device Industry
• Class II Devices
• Class III Devices
• ISO 14971
• Post-Market Surveillance