Senior Human Factors Engineer

About the role

We are seeking an experienced Senior Human Factors Engineer to lead human factors and usability engineering activities across the product development life cycle. This is not simply a validation and compliance role. We are looking for someone who is passionate about human-centered design and enjoys working directly with users to uncover insights that influence product decisions.

Responsibilities

• Plan, moderate, and execute formative and summative usability studies
• Conduct voice-of-customer research, heuristic evaluations, contextual inquiries, and exploratory concept testing
• Partner with engineering and product teams to define usability requirements and user-centered design strategies
• Ensure user capabilities, limitations, and use-related risks are appropriately addressed throughout product development
• Support risk management activities and contribute to design decisions that improve safety and usability
• Develop study protocols, research plans, reports, and regulatory documentation
• Analyze qualitative and quantitative usability data and translate findings into actionable recommendations
• Represent Human Factors Engineering on cross-functional product development teams
• Collaborate with external vendors, research partners, healthcare professionals, patients, and caregivers
• Support regulatory submissions and ensure compliance with applicable human factors standards and guidance documents
• Help shape the future user experience for innovative cancer treatment technologies

Requirements

• You are passionate about understanding how people interact with technology
• You know that successful products are not designed in conference rooms - they're shaped by observing, listening to, and learning from real users
• You enjoy facilitating conversations, moderating usability studies, and uncovering insights that others might miss
• You bring strong experience working with electromechanical medical devices and understand the unique challenges of designing products that must be both highly usable and highly reliable
• You've likely spent years working directly with users, conducting formative and summative studies, and helping product teams make better decisions through evidence-based design
• You combine technical expertise with empathy, curiosity, and strong communication skills
• You're comfortable challenging assumptions, advocating for users, and collaborating across disciplines to deliver exceptional product experiences

Qualifications

• Bachelor's degree in Human Factors Engineering, Usability Engineering, Industrial Design, Psychology, Biomedical Engineering, or a related field with 8+ years of relevant experience; or an advanced degree with 5+ years of relevant experience
• Experience leading human factors activities for Class II and/or Class III medical devices
• Strong experience planning, moderating, and executing formative and summative usability evaluations
• Experience developing study protocols, usability reports, root cause analyses, and risk assessments
• Experience working with electromechanical medical devices and hardware-based systems
• Strong understanding of IEC 62366-1, ISO 14971, ANSI/AAMI HE75, ISO 13485, and relevant FDA human factors guidance
• Excellent communication, facilitation, presentation, and technical writing skills
• Ability to work independently and influence cross-functional teams
• Experience collaborating with engineering, product management, regulatory, and clinical stakeholders

Preferred Qualifications

• Experience with Class III medical devices
• Experience moderating complex user research studies involving patients, caregivers, and healthcare professionals
• Experience supporting global regulatory submissions including EU MDR and APAC markets
• Experience with design thinking and human-centered design methodologies
• Experience working within highly regulated medical device environments
• Familiarity with oncology, patient-care, or home-use medical device environments