In this role you will collaborate on a variety of client-facing projects with other Fathom consultants and with cross-functional client teams of marketers, designers, researchers, and engineers. You will leverage your deep understanding of human factors to collaborate on medical devices and health technology products to bring new product ideas to life. You will plan and conduct user research studies with participants all around the world.

• Plan, execute, and document human factors project activities throughout the product development lifecycle. Support all stages of product development with research, user studies, usability evaluations, and analysis to identify user needs, support design improvements, plan and perform formative and summative usability studies, and identify and mitigate potential use errors.
• Develop and maintain subject matter expertise of FDA guidance and IEC standards governing medical devices and medical device software.  
• Define and document human factors plans, use specifications, task analyses, use-related risk analyses, user workflows related to product use, formative and summative reports, and HF/UE reports.
• Build positive, strong, and enduring working relationships with clients.
• Be encouraged and given the freedom to explore new areas of interest, techniques and approaches to deliver ever-higher levels of consulting service to your clients.
• Be supported to participate in professional organizations, societies, networking groups, and/or provide board service.
• Bring your own unique perspectives and strengths to our team.

You have:

• 5+ years’ experience leading the human factors design and evaluation of medical device products and interfaces
• Experience as a human factors consultant
• Experience designing and performing both formative and summative usability studies
• Experience conducting studies with patients, clinicians, and physicians
• Experience creating task analyses, use-related risk assessments, and other human factors related documentation
• Experience authoring HF/UE reports for FDA submissions
• Fluency with and ability to pragmatically interpret IEC 62366/14971/13485, ANSI/AAMI HE75, and FDA guidance documents
• Experience with digital products and user interfaces.
• Exceptional verbal, written, and visual communication skills that support the creation of high-quality deliverables and effective, meaningful client interactions
• Strong analytical, data gathering and organizational skills

Nice to have:

• Experience with CE marking and understanding of EU regulations.
• Experience responding to regulators’ responses
• Bachelor’s degree in relevant field (e.g. Human Factors/Usability, User Centered Design, Psychology, Engineering, Operations, Industrial Design) or 5+ years’ equivalent experience.

You are:

• Driven to bring clarity to ambiguous or quickly changing situations and projects.
• Comfortable working as a solo practitioner, team member/collaborator, or project lead.
• Proactive and self-motivated. Able to thrive in a self-directed culture.
• Committed to building cultural humility by continually learning and actively promoting diversity, equity, and inclusion in all aspects of our work.
• Willing and have a desire to build and grow relationships with co-workers, clients, and communities within and outside the Twin Cities.
• Excited to come together with colleagues by working in the office at least two designated days per month and attending periodic offsite team-building events.
• Open to feedback and willing to listen to a wide spectrum of perspectives.
• Able to work flexibly and efficiently in a deliverable-driven environment.
• Open to travel within the United States and around the world for client meetings and/or research and design efforts (up to 25% for certain projects).