Human Factors Specialist(Medical device)

2 weeks ago


saint paul, United States Intellectt Inc Full time

Key Responsibilities

  • Human Factors Integration: Apply principles of human factors, including cognitive, perceptual, and motor skills, to design and evaluate cardiac electrophysiology systems.
  • Collaboration & Leadership: Oversee staff and consultants on human factors tasks, fostering effective cross-functional collaboration.
  • Regulatory Compliance:
  • Work with regulatory teams on new product submissions, develop submission packages, and respond to regulatory inquiries.
  • Ensure that usability engineering methodologies meet regulatory standards and enhance value for customers.
  • Stay current on human factors regulations and best practices, advising management on process improvements and compliance.
  • Deliverables:
  • Develop usability engineering files, task analyses, and usability risk assessments.
  • Conduct usability testing at all stages of product development, from formative testing of prototypes to usability validation of final designs.
  • Strong knowledge of human factors and usability engineering principles.
  • Proven ability to work collaboratively with multidisciplinary teams.
  • Professional experience interfacing directly with clients.
  • Familiarity with medical device standards (e.g., IEC 62366, AAMI HE75, ISO 14971) and regulatory requirements for human factors engineering.
  • Excellent communication and presentation skills.



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