Senior Human Factors Engineer - ClariMed, Inc.

About Clarimed, Inc. 

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 continues to build our corporate team!  We are seeking an experienced on-site Vice President of Business Development to work with our corporate executive team and manage all aspects of sales operations, ensuring sales revenues meet or exceed goals of the company. 

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 

Job Summary: 

As a full-time Senior Human Factors Engineer at ClariMed, 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 ClariMed, we pride ourselves on being experts and having experience in a variety of products. 

 
Roles and Responsibilities: 

• Meet with clients to learn about new technologies and interpret client needs. 

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

• Author and update usability risk analyses. 

• Author formative and summative usability study protocols. 

• Plan and coordinate usability studies, including designing study models. 

• Moderate formative and summative usability studies and/or take note. 

• Data analysis to identify root cause of observed use errors. 

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

• Author Human Factors Engineering Submission Reports 

• Assist with Quality Management System efforts including Usability Engineering processes and deliverables. 

• Contribute to user interface designs by providing guidance, ideas, feedback and user-interface requirements to clients. 

• Support and prepare justifications along with clients on Human Factors strategies. 

• Support inquiries, audits, and discussions with regulatory agencies, test labs, and notified bodies. 

• Prepare and delivers Human Factors engineering trainings, webinars and contribute to research to increase industry awareness about ClariMed through conferences and publications. 

• Mentor Interns and Junior level Human Factors engineer. 

• Lead projects and communicate with key stakeholders. 

Candidate Requirements: 

• 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. 

•  Understanding of Human Factors requirements, U.S. FDA Guidance for Human Factors and International 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). 

• Technical problem solving and interpersonal skills that result in clear communication and presentation skills. 

• Experience working with diverse user demographics. 

• Ability to travel domestically (up to 25%).