Human Factors Engineering Intern -San Jose, CA - ClariMed, Inc.

Job Title: Human Factors Intern

About Clarimed:

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 Clarimed, 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.

“The premiere, human centered development and regulatory practice for medical products, point of care devices, companion and combination products, and SaMD.”

ClariMed was formed with the vision that a unique market opportunity exists to build the leader in human centered regulatory and development services for medical products. We believe that a focus on placing human factors at the core of device development and regulatory pathways translates to a “quality by design” approach that drives outsized value for patients, customers, and shareholders. We also believe that a stronger calibration to risk/benefit is emerging and will continue to be a driver of market clearance and reimbursement, which in turn will lead to clients that place an emphasis on “smarter” development.

Clarimed is an industry leader in Human Factors Engineering for medical products headquartered in Chadds Ford, PA and with sites also in California, Massachusetts, and across the UK. 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.

Job Summary:

As a Human Factors Intern at Clarimed, you will work collectively with our team to:

• Help innovative companies design safe and usable medical devices, ensuring that user experience is incorporated early and often in the design process
• Consult with established medical device companies to encourage the adoption of human factors best practices

At Clarimed, we pride ourselves on being experts and having experience in a variety of medical products including wearable sensors, surgical devices, diagnostic equipment, drug administration devices, and home-use devices.

Roles and Responsibilities:

• Author human factors engineering blog posts and articles on behalf of Clarimed, Inc.
• Conduct Literature reviews (e.g. how much force can a 5th percentile female apply?)
• Edit Human Factors outreach materials and edit training presentations
• Assist with Expert Reviews of User Manuals/Instructions
• File and organize paperwork
• Perform task analyses and user research studies for new medical device concepts
• Update usability risk analyses in collaboration with coworkers and clients
• Prepare formative and summative usability study protocols
• Plan and coordinate usability studies, including gathering equipment, designing and preparing study models, and recruiting participants
• Usability Study data entry and preliminary data analysis
• 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 co-author Human Factors Engineering Submission Reports

Candidate Requirements:

• Studying Engineering; BS in Mechanical Engineering, Human Factors Engineering, Industrial Engineering or Biomedical Engineering. MS strongly preferred.
• Familiarity with the 2016 FDA Guidance - Applying Human Factors and Usability Engineering to Medical Devices.
• Familiarity with the human factors standards such as IEC 62366:2007 and IEC 62366-1:2015.
• Superior ability to write accurate, clear, and concise protocols, reports, operating procedures, and other documents 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.
• This is an onsite internship, all interns must be located in San Jose, CA.