Human Factors Engineer
Our mission is simple...to SAVE LIVES lost to preventable medical errors. Every year there are over 210,000 preventable medical errors which lead to death. Our goal is to do everything in our power to
reduce this number significantly. Following U.S. Food & Drug Administration requirements, we do this by conducting usability studies for testing of medical products.
At UserWise, we co-create safe and usable medical products with our clients. In our studies, we recruit real-life people and observe them simulating the use of medical products to reveal ways to improve these products for our clients.
UserWise is an industry leader in Human Factors Engineering for medical products headquartered in San Jose, California and with sites also in Ohio, Oregon, and Texas. We are looking for someone who wants to make a significant impact in the medical field to not only prevent deaths, but also to improve patient care worldwide.
As a full-time Senior Human Factors Engineer at UserWise, you will be helping innovative companie 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. At UserWise, we pride ourselves on being experts and having experience in a variety of products including wearable sensors, surgical devices, diagnostic equipment, drug administration devices, and home-use devices. UserWise is a small company that emphasizes work-life balance and working from home is often an option (client-permitting). We are located at 919 The Alameda, San Jose, California.
Roles and Responsibilities
- Meet with clients to learn about new technologies and interpret client needs to consult on usability
- Perform task analyses and user research studies for new medical device
- Author and update usability risk analyses in collaboration with coworkers and clients
- Author formative and summative usability study protocols
- Plan and coordinate usability studies, including gathering equipment, designing and preparing study models, and recruiting participants
- Moderate formative and summative usability studies and/or take note.
- Data analysis and analysis of usability study video footage to identify root cause of observed use errors
- Prepare and/or assist with formal usability study reports
- Create usability engineering files and author Human Factors Engineering Submission Reports
- Assist with quality system work such as development of usability engineering processes for clients and UserWise
- Contribute to user interface designs by providing guidance, ideas, and feedback to clients
- Author user-interface requirements documents
- Prepare justifications and partner with clients on Human Factors strategy
- Support inquiries, audits, and discussions with regulatory agencies, test labs, and notified bodies.
- Prepare and/or provide human factors engineering trainings and webinars
- Author human factors engineering blog posts and articles on behalf of UserWise
- Contribute to human factors research to raise industry awareness about UserWise (e.g., speaks
at conferences, authors articles in industry publications)
- 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; perform root cause analysis astutely)
- At least 5 years of experience in medical device, or similarly regulated, industry
- Demonstrated understanding of Human Factors requirements, both U.S. (i.e. the 2016 FDA
Guidance for Human Factors) and international (i.e. IEC 62366)
- 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 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)
- Excellent technical problem solving and interpersonal skills that result in clear verbal communication and presentation skills
- Experience working with a wide variety of population demographic is desired
- Ability to travel domestically (up to 30%)
Job Types: Full-time
Learn more about our Company Culture.
Email your Cover Letter and Resume to HR at HR@UserWiseConsulting.com