Human Factors Manager

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. Position Summary The Human Factors Manager is a key leadership role responsible for guiding human factors strategy, directing project execution, developing talent, overseeing client relationships, and ensuring technical excellence. This role combines hands‑on human factors expertise with people leadership, project oversight, and client‑facing partnership. You will lead a team of Human Factors Engineers, manage multi‑program portfolios, and ensure that ClariMed’s usability engineering practice maintains the highest standards of quality, compliance, and innovation. Key Responsibilities Lead, mentor, and develop Human Factors Engineers across levels. Provide ongoing coaching, technical guidance, and performance feedback. Manage resource planning, staffing, and workload balancing across programs. Foster a collaborative, high‑performance team culture. Human Factors Strategy & Technical Oversight Direct the planning and execution of formative and summative usability studies. Review and approve HF protocols, test plans, reports, and usability documentation. Oversee development of usability risk analyses, HF engineering strategies, and regulatory documentation. Ensure adherence to FDA HF guidance, IEC 62366, quality system requirements, and industry best practices. Serve as an escalation point for complex human factors challenges across programs. Project & Program Management Manage HF project portfolios, ensuring quality, timelines, and budget alignment. Guide cross‑functional teams to integrate human factors throughout product development. Direct complex multi‑program HF strategies, including outsourced or vendor‑supported activities. Oversee coordination with third‑party vendors, contractors, and partners to ensure seamless execution. Client Partnerships & Business Growth Build and maintain strong client relationships across projects and strategic accounts. Lead or support business development through proposals, scoping, and client presentations. Represent ClariMed as a subject matter expert in client meetings and regulatory discussions. Organizational Impact & Innovation Contribute to development and refinement of HF processes, SOPs, and quality standards. Drive process improvements, operational efficiencies, and methodological innovation. Participate in publications, conference presentations, and thought leadership initiatives. Support departmental planning, budgeting, and long‑term organizational strategy. Required Knowledge, Skills, and Abilities Deep knowledge of FDA Human Factors Guidance, IEC 62366, and global regulatory expectations. Strong technical expertise in medical device usability engineering across the full product lifecycle. Demonstrated success managing HF teams and leading complex HF projects or programs. Excellent communication, leadership, and client relationship skills. Proficiency in developing HF strategies, risk analyses, and regulatory documentation. Experience with quality management systems and regulatory submissions. Strong business acumen, problem‑solving ability, and decision‑making skills. Experience presenting at conferences or contributing to industry publications is preferred. Technical leadership and oversight Team development and coaching Strategic thinking and decision‑making Effective delegation and project prioritization Resource and workload management Clear communication and influence Stakeholder and client engagement Quality management and continuous improvement Change management and adaptability Minimum Qualifications Education: M.S./M.A. in Human Factors Engineering, Cognitive Psychology, Biomedical Engineering, or a related field. Experience: 5–7+ years of human factors experience in the medical device or combination‑product industry. 2–3+ years of experience managing or mentoring technical teams. Proven experience leading HF studies, regulatory documentation, and complex client programs. Why Join ClariMed? Opportunity to influence the design of innovative medical technologies. Collaborative environment with experienced HF, UX, engineering, and regulatory professionals. Meaningful work that directly impacts patient safety and user experience. Growth opportunities including leadership development, industry engagement, and multi‑site program ownership. #J-18808-Ljbffr