Associate Director, Human Factors Engineering

pAs 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. /p pIn 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. /p h3Your Tasks Responsibilities /h3 h3Human Factors Usability Strategy /h3 ul liDevelop and implement global human factors strategies for product design and development. /li liIdentify critical user interactions, use environments, and potential risks impacting safety and efficacy. /li liIntegrate human factors early in the design process to minimize risk and optimize usability. /li /ul h3Design Development Support /h3 ul liLead human factors design inputs, design controls, and usability engineering throughout the product lifecycle. /li liGuide interface design, labeling, and user instructions to improve user experience. /li liCollaborate with RD, Engineering, and Product Development teams to ensure HF considerations are incorporated into product concepts and prototypes. /li /ul h3Risk Assessment Validation /h3 ul liConduct human factors risk assessments in alignment with ISO 14971 and company risk management procedures. /li liPlan and execute formative and summative usability studies. /li liAnalyze study data to identify usability issues and recommend design modifications. /li liDocument human factors and usability validation activities for regulatory submissions. /li /ul h3Regulatory Compliance /h3 ul liSupport preparation of HF-related sections of regulatory submissions (FDA, EU MDR, and other global authorities). /li liEnsure HF programs meet all relevant international standards and guidance. /li liServe as a subject matter expert for regulatory inspections related to human factors. /li /ul h3Cross-Functional Leadership /h3 ul liPartner with Clinical, Regulatory, Quality, and Manufacturing teams to ensure integrated design development. /li liMentor and develop junior HF staff. /li liParticipate in project planning, milestone reviews, and senior leadership meetings. /li /ul h3Your Skills and Experience /h3 ul liMaster’s or PhD in Human Factors, Industrial Design, Human-Computer Interaction, Ergonomics, Biomedical Engineering, or a related field. /li li8–12 years of experience in human factors engineering, usability, or related product development. /li liExperience in medical devices, combination products, or healthcare technologies. /li liProven experience conducting formative and summative usability studies. /li liKnowledge of human factors standards (IEC 62366, FDA guidance, ISO 14971). /li liExpertise in human factors and usability engineering. /li liStrong understanding of design controls and risk management. /li liExperience with usability study design, execution, and analysis. /li liRegulatory knowledge for HF submissions and compliance. /li liCross-functional collaboration and project leadership. /li liExcellent written and verbal communication skills. /li /ul h3What We Offer /h3 ul liA senior leadership role shaping the usability and safety of innovative healthcare products. /li liThe opportunity to drive global human factors strategies and influence product development. /li liCollaboration with diverse, cross-functional teams in a dynamic environment. /li liProfessional development and advancement opportunities. /li liCompetitive compensation and benefits, including flexible working arrangements. /li liA culture that values innovation, quality, and continuous improvement. /li /ul #J-18808-Ljbffr