Job Description

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 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 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. #J-18808-Ljbffr ClariMed, Inc.

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