Sr. Human Factors Engineer at ClariMed

About the RoleAs a Senior Human Factors Engineer at ClariMed you will lead human factors activities across the full product development lifecycle. Youll 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 Youll DoLead Human Factors Research & AnalysisConduct 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 TestingDevelop 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 DocumentationAuthor 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 ClariMeds quality system requirements.Collaborate With Clients & Product TeamsProvide 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 ClariMeds GrowthMentor junior HF team members and interns.Deliver presentations trainings workshops or conference contributions.Support business development through proposal input and client engagement.What Were Looking ForRequired Skills & ExperienceStrong 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 & ExperienceM.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.57 years of experience in the medical device or related industry (or equivalent combination of experience and education).Why Join ClariMedWork 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.Required Experience:Senior IC Key Skills Invoicing,Facilities Management,HVAC,AIX,Air Pressure Handling,AX Employment Type : Full-Time Experience: years Vacancy: 1