Senior Human Factors Engineer

Johnson & Johnson Johnson & Johnson · Pharma · Cincinnati, OH +1

Senior Human Factors Engineer for a robotic surgical system, focusing on usability, risk assessment, and regulatory compliance in the healthcare domain.

What you'd actually do

  1. Support the development and execution of human factors and usability strategies from initial concept through post-market support, facilitate usability efforts across product lines and programs with general direction.
  2. Address sophisticated issues that affect the program team, contributing to projects that identify and analyze multiple factors, while applying attention to detail in choosing appropriate methods and techniques for evaluations.
  3. Collaborate with R&D, Marketing, Medical Safety, Regulatory Affairs, Clinical Engineering, and Quality Engineering to design, evaluate, and provide guidance on solutions and their user-related impact throughout the entire care process, ensuring a balance of the needs of users, surgeons, hospital staff, and patients in alignment with the technical development roadmap.
  4. Prepare precise and concise usability engineering documents for multiple projects in a timely manner, including task analyses, usability risk assessments, use specifications, test reports and root cause analyses, and usability engineering plans.
  5. Act as internal expert and advisor on human factors (including ergonomic and anthropometric principles) and continuously improve our HF process to align it with standards and guidances while also customizing it for the specific realities of our business.

Skills

Required

  • Human Factors Engineering (HFE)
  • Usability Engineering
  • Cognitive Science
  • Anthropology
  • Biomedical Engineering
  • product development for Medical Devices
  • human factors engineering process
  • research
  • planning
  • risk assessment
  • user interface requirements
  • regulatory submissions
  • negotiate with stakeholders
  • risk management documentation
  • planning usability testing
  • executing usability testing
  • documenting usability testing
  • reporting usability testing
  • moderation of studies
  • user workflow designs
  • user interface designs
  • negotiation of design recommendations
  • IEC 62366
  • FDA guidance on human factor

Nice to have

  • Post-graduate degrees

What the JD emphasized

  • human factors
  • usability
  • medical robotics
  • regulatory submissions
  • IEC 62366
  • FDA guidance