PbThe Opportunity /b /ppAs Associate Director, Human Factors Design and Development, you will lead the integration of human factors engineering and usability strategies for medical devices, combination products, and healthcare technologies. Your work will ensure that products are safe, effective, and user-friendly—directly impacting patient outcomes and user experience. /ppIn this role, you will collaborate with cross-functional teams across Design, Engineering, Regulatory Affairs, Quality, and Clinical to embed human factors principles throughout the product lifecycle. You will drive global strategies, support regulatory submissions, and mentor junior staff, helping shape the future of healthcare innovation. /ppbYour Tasks Responsibilities /b /ppbHuman Factors Usability Strategy /b /pliDevelop and implement global human factors strategies for product design and development. /liliIdentify critical user interactions, use environments, and potential risks impacting safety and efficacy. /liliIntegrate human factors early in the design process to minimize risk and optimize usability. /lipbDesign Development Support /b /pliLead human factors design inputs, design controls, and usability engineering throughout the product lifecycle. /liliGuide interface design, labeling, and user instructions to improve user experience. /liliCollaborate with RD, Engineering, and Product Development teams to ensure HF considerations are incorporated into product concepts and prototypes. /lipbRisk Assessment Validation /b /pliConduct human factors risk assessments in alignment with ISO 14971 and company risk management procedures. /liliPlan and execute formative and summative usability studies. /liliAnalyze study data to identify usability issues and recommend design modifications. /liliDocument human factors and usability validation activities for regulatory submissions. /lipbRegulatory Compliance /b /pliSupport preparation of HF-related sections of regulatory submissions (FDA, EU MDR, and other global authorities). /liliEnsure HF programs meet all relevant international standards and guidance. /liliServe as a subject matter expert for regulatory inspections related to human factors. /lipbCross-Functional Leadership /b /pliPartner with Clinical, Regulatory, Quality, and Manufacturing teams to ensure integrated design development. /liliMentor and develop junior HF staff. /liliParticipate in project planning, milestone reviews, and senior leadership meetings. /lipbYour Skills and Experience /b /pliMaster’s or PhD in Human Factors, Industrial Design, Human-Computer Interaction, Ergonomics, Biomedical Engineering, or a related field. /lili8–12 years of experience in human factors engineering, usability, or related product development. /liliExperience in medical devices, combination products, or healthcare technologies. /liliProven experience conducting formative and summative usability studies. /liliKnowledge of human factors standards (IEC 62366, FDA guidance, ISO 14971). /liliExpertise in human factors and usability engineering. /liliStrong understanding of design controls and risk management. /liliExperience with usability study design, execution, and analysis. /liliRegulatory knowledge for HF submissions and compliance. /liliCross-functional collaboration and project leadership. /liliExcellent written and verbal communication skills. /lipbWhat We Offer /b /pliA senior leadership role shaping the usability and safety of innovative healthcare products. /liliThe opportunity to drive global human factors strategies and influence product development. /liliCollaboration with diverse, cross-functional teams in a dynamic environment. /liliProfessional development and advancement opportunities. /liliCompetitive compensation and benefits, including flexible working arrangements. /liliA culture that values innovation, quality, and continuous improvement. /lippbbAbout CSL Behring /b /b /p /ppCSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. /ppbr/CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. /ppTo learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at. /ppbOur Benefits /b /p