What are the responsibilities and job description for the Human Factor Engineering Manager position at ClariMed, Inc.?
About Clarimed, Inc.
We are headquartered in Chadds Ford, PA We are driving to become:
“The premium, 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 stakeholders. 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.
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
Position Summary:
As a full-time Human Factors Engineering Manager at ClariMed, you will be empowering human factors engineers to consult innovative companies to design safe and usable medical devices, ensuring that user experience is incorporated early and often in the design process. At ClariMed, 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.
• Consult with clients to interpret needs and incorporate HF principles into medical device design
• Author usability risk analyses and study protocols
• Moderate and analyze usability studies to identify use errors
• Assist with HF submissions, study reports, UI requirements, and regulatory processes
• Develop and deliver HF training, education, conferences, and publications
• Travel domestically up to 25% of the time
Required Qualifications:
• Master’s in Human Factors or related field
• 5 years in medical devices or regulated industry
• Expertise in HF standards, FDA guidance, and regulatory compliance
• Technical problem-solving and collaboration skills
• Experience working across diverse user populations
