Ph3The Opportunity /h3pAs 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. In 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. /ph3Your Tasks Responsibilities /h3h3Human Factors Usability Strategy /h3pDevelop and implement global human factors strategies for product design and development. Identify critical user interactions, use environments, and potential risks impacting safety and efficacy. Integrate human factors early in the design process to minimize risk and optimize usability. /ph3Design Development Support /h3pLead human factors design inputs, design controls, and usability engineering throughout the product lifecycle. Guide interface design, labeling, and user instructions to improve user experience. Collaborate with RD, Engineering, and Product Development teams to ensure HF considerations are incorporated into product concepts and prototypes. /ph3Risk Assessment Validation /h3pConduct human factors risk assessments in alignment with ISO 14971 and company risk management procedures. Plan and execute formative and summative usability studies. Analyze study data to identify usability issues and recommend design modifications. Document human factors and usability validation activities for regulatory submissions. /ph3Regulatory Compliance Support /h3pPrepare HF‑related sections of regulatory submissions (FDA, EU MDR, and other global authorities). Ensure HF programs meet all relevant international standards and guidance. Serve as a subject‑matter expert for regulatory inspections related to human factors. /ph3Cross‑Functional Leadership /h3pPartner with Clinical, Regulatory, Quality, and Manufacturing teams to ensure integrated design development. Mentor and develop junior HF staff. Participate in project planning, milestone reviews, and senior leadership meetings. /ph3Your Skills and Experience /h3ulliMaster’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. /li /ulh3What We Offer /h3pA senior leadership role shaping the usability and safety of innovative healthcare products. The opportunity to drive global human factors strategies and influence product development. Collaboration with diverse, cross‑functional teams in a dynamic environment. Professional development and advancement opportunities. Competitive compensation and benefits, including flexible working arrangements. A culture that values innovation, quality, and continuous improvement. /ph3Equal Opportunity Employer /h3pCSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit our accessibility statement. CSL Global Privacy Notice for Job Applicants and Candidates. /p /p #J-18808-Ljbffr