Sr. Human Factors Engineer

About the Role 

As a Senior Human Factors Engineer at ClariMed, you will lead human factors activities across the full product development lifecycle. You’ll partner directly with clients, guide usability strategy, and execute formative and summative evaluations for medical device programs. This role is ideal for someone who is excited by hands-on research, technical rigor, and the opportunity to shape products that improve patient and clinician outcomes. 

You will also contribute to the growth of the Human Factors team by mentoring junior engineers, supporting business development efforts, and representing ClariMed through presentations, trainings, and thought leadership. 

What You’ll Do 

Lead Human Factors Research & Analysis 

• Conduct task analyses, user research, and contextual inquiries. 

• Develop and maintain usability risk analyses (e.g., URAs, UFMEAs). 

• Identify user needs, use-related hazards, and risk controls. 

Design & Execute Usability Testing 

• Develop formative and summative study protocols. 

• Plan and coordinate usability studies, including scenario design and model/mock-up requirements. 

• Moderate and observe usability testing with both healthcare professionals and lay users. 

• Analyze qualitative and quantitative data to determine root causes of observed use errors. 

Create High-Quality Documentation 

• Author usability study reports and HF deliverables for regulatory submissions. 

• Prepare Human Factors Engineering (HFE) Submission Reports in accordance with FDA guidance, IEC 62366, and international standards. 

• Ensure documentation meets ClariMed’s quality system requirements. 

Collaborate With Clients & Product Teams 

• Provide user interface design input and usability-driven recommendations. 

• Develop HF strategies for new devices, product updates, and legacy systems. 

• Support clients during regulatory audits, inquiries, and submission-related discussions. 

• Lead project communications and manage timelines, deliverables, and expectations. 

Mentor & Contribute to ClariMed’s Growth 

• Mentor junior HF team members and interns. 

• Deliver presentations, trainings, workshops, or conference contributions. 

• Support business development through proposal input and client engagement. 

What We’re Looking For 

Required Skills & Experience 

• Strong knowledge of Human Factors principles, FDA HF Guidance, IEC 62366, and applicable international standards. 

• Experience designing and conducting usability studies for medical devices. 

• Deep understanding of medical device development and regulatory pathways. 

• Strong communication and technical writing skills with experience preparing HF documentation. 

• Ability to synthesize complex information and present it clearly to diverse audiences. 

• Experience working with both healthcare professionals and lay users. 

• Proficiency with Microsoft Office Suite. 

Education & Experience 

• M.A./M.S. in Human Factors Engineering, Biomedical Engineering, or related field preferred. 

• B.A./B.S. in a related field (Human Factors, Engineering, Psychology, Cognitive Science, Industrial Design) also accepted. 

• 5–7 years of experience in the medical device or related industry (or equivalent combination of experience and education). 

Why Join ClariMed? 

• Work on cutting-edge medical device technologies that have real-world impact. 

• Collaborative, people-focused culture with opportunities for growth. 

• Exposure to a wide variety of products, clients, and project types. 

• Opportunities to contribute to industry thought leadership. 

• Competitive compensation and benefits package.