R&D Engineer - Human Factors - Intellectt INC

Job Title: R&D Engineer - Human Factors

Location: St. Paul, MN 55117
Duration: 12+ Months
Work Arrangement: Onsite 4 days/week, remote 1 day/week

We are seeking experienced Human Factors Engineers to join our R&D division within the Electrophysiology Systems team, a part of the Atrial Fibrillation business unit. The role involves applying human factors and ergonomics expertise in product development, specifically for cardiac electrophysiology systems.

• Education: M.S. in Human Factors Engineering, UX Design, Cognitive Psychology, Biomedical Engineering (with extensive human factors coursework), or a related discipline.
• Experience: Minimum 5 years in human factors/usability engineering for hardware-software systems, with a preference for 10+ years, particularly in medical device development.
• Skills:
  • 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.

• 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.

Represent the organization in regulatory meetings, human factors conferences, and standards committees to further establish the company's leadership in the field