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Senior Consultant, Human Factors Engineering

Job in Minneapolis, Hennepin County, Minnesota, 55401, USA
Listing for: Flex Vascular
Full Time position
Listed on 2026-07-19
Job specializations:
  • Business
    Regulatory Compliance Specialist, Business Analyst
Job Description & How to Apply Below

Senior Consultant, Human Factors Engineering

Fathom Consulting is seeking an experienced, curious, and service-minded human factors professional to help our clients design safer, more usable medical devices and digital health experiences. In this role, you'll collaborate with other Fathom consultants and cross-functional client teams to bring a human-centered perspective to product development—shaping research, design, evaluation, and documentation across the product lifecycle.

What This Role Looks Like

This role is designed for someone who brings deep human factors expertise, enjoys solving complex product challenges, and thrives in a collaborative consulting environment. You will serve clients across a range of medical technology engagements, focusing on several core areas.

  • Lead and support human factors activities across the product development lifecycle—from early research and design input to concept evaluation through formative studies, summative testing, and final report creation.
  • Define and author key human factors deliverables such as use specifications, task analyses, use-related risk analyses, user workflows, study plans, and study reports.
  • Apply expert review methods—including heuristic evaluations, cognitive walkthroughs, and structured assessments—to strengthen product usability and safety.
  • Leverage knowledge of human factors practices, guidance documents, interaction with regulatory bodies to advise clients throughout the process
  • Build strong, trusted relationships with clients and work seamlessly with cross-functional teams to move projects forward with clarity and confidence.

In addition, you will have opportunities to grow your practice and your impact.

  • Explore new areas of interest, methods, and approaches that help you broaden your expertise and deliver ever-higher levels of consulting service.
  • Participate in professional organizations, societies, networking groups, and community or board service in ways that support your development and broaden your perspective.
Relevant Experience And Mindset

The qualifications below are meant to guide, not limit. If your background doesn't match every bullet but you feel your experience is aligned with the role, we'd love to hear from you.

You have 5+ years' experience in:
  • Leading the human factors design and evaluation of medical device products, interfaces, and workflow
  • Designing and conducting both formative and summative usability studies with patients, clinicians, and other relevant users
  • Creating task analyses, use-related risk assessments, and other core human factors documentation
  • Authoring HF/UE reports and contributing to documentation that supports FDA submissions
  • Interpreting and applying IEC 62366/14971/13485, ANSI/AAMI HE75, and FDA guidance in practical, project-based contexts
  • Working across physical and digital products and user interfaces
  • Communicating clearly through strong verbal, written, and visual deliverables that support client understanding and action
  • Bringing strong analytical, data gathering, and organizational skills to complex client work
Nice To Have:
  • Experience working as a human factors consultant
  • Experience with CE mark and an understanding of EU regulations
  • Experience responding to regulator questions or feedback
  • A bachelor's degree in a relevant field (e.g., Human Factors/Usability, User-Centered Design, Psychology, Engineering, Operations, Industrial Design) or equivalent experience
You Are Comfortable With:
  • Bringing clarity to ambiguous or fast-changing situations and helping teams move forward with confidence
  • Working effectively as an individual contributor, collaborator, or project lead depending on what the work requires
  • Taking initiative, working independently, and thriving in a self-directed culture
  • Building cultural humility by continually learning and actively supporting diversity, equity, and inclusion in all aspects of your work
  • Building and growing strong relationships with co-workers, clients, and communities within and outside the Twin Cities
  • Coming together with colleagues by working in the office on designated team days and attending periodic offsite team-building events
  • Listening openly, embracing feedback, and…
Position Requirements
10+ Years work experience
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