Human Factors Engineer

About the Role

Support the design, development, and validation of surgical robotics systems by applying human-centered design principles throughout the product lifecycle. This role partners closely with engineering, clinical, design, regulatory, and medical affairs teams to ensure robotic technologies are safe, intuitive, and effective for surgeons and operating room staff.

Responsibilities

• Human Factors & Usability Engineering
  • Apply human factors engineering methodologies throughout medical device development programs.
  • Conduct user needs analyses, contextual inquiries, workflow assessments, and task analyses.
  • Identify use-related hazards and contribute to risk management activities.
  • Develop use scenarios, critical task analyses, and usability requirements.
  • Generate design recommendations based on user feedback and observational research.
  • Support formative and summative usability testing activities in accordance with FDA and international human factors guidance.
• Surgical Robotics Evaluation
  • Collaborate with robotics engineers, systems engineers, surgeons, and clinical teams to evaluate robotic-assisted surgical workflows.
  • Assess surgeon interaction with key device elements and supporting technologies.
  • Evaluate cognitive workload, user performance, and procedural efficiency during simulated procedures.
  • Provide actionable recommendations to improve system usability, safety, and surgeon experience.
• Cadaver Lab & Simulation Research
  • Design, coordinate, and execute cadaver-based usability studies and validation activities.
  • Facilitate simulations involving surgeons, fellows, residents, surgical technologists, and operating room personnel.
  • Collect performance metrics, observational data, video recordings, and participant feedback during procedures.
  • Analyze user interactions under realistic surgical conditions to identify usability challenges and design opportunities.
  • Manage study logistics, documentation, equipment setup, and protocol execution within laboratory environments.
  • Ensure compliance with biosafety, laboratory, and ethical research procedures.
• Data Analysis & Reporting
  • Analyze qualitative and quantitative data from usability studies.
  • Develop study reports, executive summaries, and design recommendations.
  • Present findings to cross-functional stakeholders and senior leadership.
  • Support regulatory documentation including Human Factors Engineering reports, validation plans, and risk assessments.
• Cross-Functional Collaboration
  • Partner with:
    • Systems Engineering
    • Clinical Affairs
    • Regulatory Affairs
    • Quality Engineering
    • Industrial Design
    • Software Development
    • Marketing and Product Management
  • Serve as the voice of the user throughout product development efforts.
  • Influence product strategy through evidence-based usability insights.

Qualifications

• Required
  • Bachelor's degree in Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Cognitive Psychology, Ergonomics, or related field.
  • 2-5+ years of experience in human factors, usability engineering, medical devices, healthcare technology, or related industries.
  • Experience designing and conducting usability studies and user research.
  • Strong knowledge of human-centered design principles and risk-based usability engineering.
  • Experience analyzing user performance data and translating findings into design recommendations.
  • Excellent communication and stakeholder management skills.
• Preferred
  • Master's degree in Human Factors Engineering, Biomedical Engineering, Psychology, Ergonomics, or related discipline.
  • Experience supporting medical device development programs.
  • Familiarity with FDA human factors guidance and IEC 62366.
  • Experience with robotic-assisted surgical systems or advanced surgical technologies.
  • Hands-on experience conducting cadaver labs, simulated surgical procedures, or operating room workflow studies.
  • Knowledge of surgical anatomy, minimally invasive surgery, or operating room environments.
  • Experience using video coding, observational research, and statistical analysis tools.

Skills

• Human Factors Engineering
• Usability Testing
• User Research
• Surgical Robotics
• Cadaver Lab Operations
• Simulation-Based Research
• Task Analysis
• Risk Analysis
• Design Validation
• Clinical Research
• Ergonomics
• Data Analysis
• Cross-Functional Leadership
• Medical Device Development