As a full-time Usability Engineering Consultant at UserWise, 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. 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 engineering
- Perform task analyses and user research studies for new medical device concepts
- 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 notes.
- 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.
- Oversee the maintenance of a quality system for UserWise
- Contribute to user interface designs by providing guidance, ideas, and feedback to clients
- Author user-interface requirements documents
- Prepare and/or provide human factors engineering trainings and webinars
- Author human factors engineering blog posts and articles on behalf of UserWise, Inc.
- Offer Quality Engineering consulting and authorship of quality engineering documentation (as an add-on to human factors services)
- BS in Mechanical Engineering, Human Factors Engineering, or Biomedical Engineering. MS strongly preferred
- At least 2 years of experience in medical device, or similarly regulated industry
- Experience working within a quality system, preferably at a fortune 500 medical device or pharmaceutical company
- Familiarity with the 2016 FDA Guidance for Human Factors and human factors standards such as IEC 62366
- Superior ability to write accurate, clear, and concise protocols, reports, operating procedures, etc. in a timely manner
- Ability to analyze and synthesize large quantities of information into usable communications
- Ability to interface with customers in a highly professional manner
- Excellent verbal communication and presentation skills
- Ability to travel domestically (up to 30%)