Job Summary:

As a full-time Senior Human Factors Engineer at UserWise, a ClariMed Company you will be helping innovative companies design safe and usable medical devices, ensuring that user experience is incorporated early and often in the design process. You will also consult with established medical device companies to encourage the adoption of Human Factors best practices. 

Roles and Responsibilities:

  • Meet with clients to learn about new technologies and interpret client needs.
  • Conduct task analyses and user research studies for new medical device concepts.
  • Author and update usability risk analyses.
  • Author formative and summative usability study protocols.
  • Plan and coordinate usability studies, including designing study models.
  • Moderate formative and summative usability studies and/or take note.
  • Data analysis to identify root cause of observed use errors.
  • Prepare and/or assist with formal usability study reports.
  • Author Human Factors Engineering Submission Reports.
  • Assist with Quality Management System efforts, including usability engineering processes and deliverables.
  • Contribute to user interface designs by providing guidance, ideas, feedback and user-interface requirements to clients.
  • Support and prepare justifications along with clients on Human Factors strategies.
  • Support inquiries, audits, and discussions with regulatory agencies, test labs, and notified bodies.
  • Prepare and deliver Human Factors engineering trainings, webinars and contribute to research to increase industry awareness about ClariMed through conferences and publications.
  • Mentor interns and junior-level Human Factors engineers.
  • Lead projects and communicate with key stakeholders.


Candidate Requirements:

  • M.A./M.S. in Human Factors Engineering or Biomedical Engineering preferred. B.A./B.S. in Human Factors Engineering, Biomedical Engineering, or Mechanical Engineering also acceptable.
  • Ability to effectively lead Human Factors process (i.e. design a Human Factors study, moderate, observe, and facilitate usability testing, and perform root cause analysis)
  • At least 5 years of experience in medical device, or similarly regulated industry.
  • Experienced in usability standards and risk management such as IEC 62366-1, ANSI HE75, ISO 14971, and FDA Human Factors guidance.
  • Strong understanding of medical device product design and regulatory processes.
  • Experience working within a quality system, preferably at a Fortune 500 medical device or pharmaceutical company.
  • Proficiency in devising a successful human factors strategy for a new product.
  • Ability to collect and synthesize large quantities of information across the broader team into usable communications (i.e., protocols, reports, operating procedures).
  • Experience working with diverse user demographics.
  • Ability to travel domestically (up to 25%).
  • Ability to be on-site in San Jose, CA, Cambridge/Boston, MA, Chadds Ford PA, Cambridge, UK