About ClariMed, Inc.

ClariMed is a human-centered development and regulatory practice for medical products developed by Pharmaceutical and Medical device manufacturers. Our best-of-breed professional services cultivate innovation while ensuring the safe and effective use of medical products.

Operating out of Chadds Ford, PA with offices in San Jose, Boston, and Cambridge, UK, ClariMed is building a global, boutique professional services practice that provides human centered design, development and regulatory services to medical device and pharmaceutical manufacturers. With a grounding in quality by design, creativity and risk mitigation from concept inception through pilot lot delivery, we intend to reduce time to market, enhance product quality and convey a compelling risk/benefit positioning for our clients. We will achieve this by intentionally coupling the flexibility of a boutique offering with the breadth of services of a global business, while avoiding the conflicts that come with manufacturing and clinical operations. Visit us at www.ClariMed.com.

At ClariMed

• We believe in excellence accelerated.
• We believe in caring and kindness.
• We believe in creating solutions through thinking without boundaries.
• We believe that everyone has a voice and we accept, embrace, and celebrate everyone for all of who they are and provide them with an environment to become who they are meant to be.
• We believe in setting and receiving expectations to ensure that there is clarity and purpose in our actions.
• We believe everyone has something to learn and something to teach - we are life-long learners and educators.

About the Role 

As a Human Factors Engineer Intern at ClariMed, you will work closely with our human factors team to support usability research and engineering activities throughout the medical device development process. You will contribute to projects that help innovative companies design safe and intuitive medical devices while gaining hands-on experience in human factors engineering and usability evaluation. 

You will also support established medical device companies in adopting human factors best practices as part of regulatory and product development efforts. 

Key Responsibilities 

Human Factors Research & Analysis 

• Conduct literature reviews related to human factors and medical device usability. 

• Perform task analyses and support user research studies for new medical device concepts. 

• Assist with expert reviews of user manuals and instructions for use (IFUs). 

• Update usability risk analyses in collaboration with team members and clients. 

Usability Testing Support 

• Assist in preparing formative and summative usability study protocols. 

• Support planning and coordination of usability studies, including preparing study materials and models. 

• Assist with usability study data entry and preliminary data analysis. 

• Review usability study video footage to help identify root causes of observed use errors. 

Participant Recruitment 

• Assist with participant outreach, screening, scheduling, and communications. 

• Maintain recruitment trackers and participant databases. 

• Coordinate study schedules and ensure all required documentation is complete. 

Documentation & Communication 

• Prepare and/or assist with formal usability study reports. 

• Create usability engineering files and contribute to Human Factors Engineering submission reports. 

• Author or assist with human factors blog posts and articles on behalf of ClariMed. 

• Edit human factors outreach materials and training presentations. 

Operations & Administrative Support 

• Provide general administrative and project support to human factors and cross-functional teams. 

• Help manage project files, trackers, and internal systems. 

• Support proposal formatting and internal materials as needed. 

• Assist with coordination between commercial, research, and execution teams. 

Project Support 

• File and organize project documentation and research materials. 

• Collaborate with human factors engineers and project teams on active client engagements. 

• Participate in internal discussions and contribute to project planning activities. 

Requirements 

Education 

• Currently pursuing a Bachelor’s or Master’s degree in Mechanical Engineering, Human Factors Engineering, Industrial Engineering, Biomedical Engineering, Psychology, Cognitive Science, or a related discipline. 

• Students enrolled in Human Factors, Ergonomics, Biomedical Engineering, or related graduate programs are especially encouraged to apply. 

Knowledge & Skills 

• Familiarity with human factors regulatory guidance such as FDA’s “Applying Human Factors and Usability Engineering to Medical Devices” (2016) and related global regulatory expectations. 

• Familiarity with human factors standards such as IEC 62366-1. 

• Strong ability to write accurate, clear, and concise protocols, reports, operating procedures, and other documentation. 

• Ability to analyze and synthesize large quantities of information into clear communications. 

• Ability to interact professionally with clients and collaborators. 

• Excellent verbal communication and presentation skills. 

Why Join ClariMed? 

• Gain hands-on experience working on real-world medical device projects. 

• Learn from experienced human factors professionals in a collaborative environment. 

• Exposure to a wide range of technologies and usability research methods. 

• Opportunity to contribute to products that improve patient care and clinical outcomes.