Associate Director Engineering
Scorpion Therapeutics, Thousand Oaks, CA, United States
Role Summary
Associate Director, Human Factors & Usability Engineering (HF/UE) provides strategic and operational leadership for the integration of human factors, usability, and user-centered risk management across Amgen’s product portfolio. This role ensures human factors and usability principles are embedded throughout the product lifecycle—from early concept development through post-market surveillance—to deliver safe, effective, and intuitive products for patients, caregivers, and healthcare professionals. Responsibilities
Lead, develop, and mentor a high-performing human factors and usability engineering team. Build enterprise capability in human factors and usability by establishing scalable processes, tools, and best practices. Champion the integration of human factors, usability, and user-centered design into product development processes. Define and drive HF/UE strategy aligned with regulatory requirements, development milestones, and quality systems. Oversee planning and execution of formative and summative human factors studies in alignment with FDA, EMA, MDR, ISO 62366, and global standards. Ensure seamless integration of HF/UE activities within design controls and risk management (ISO 14971). Author and review HF/UE documentation including plans, use-related risk analyses, validation protocols, reports, and regulatory responses. Integrate use-related risk management across the product lifecycle to minimize on-market risk. Collaborate cross-functionally with Device Engineering, Regulatory Affairs, Quality, Medical, Packaging, Manufacturing, and Operations teams. Provide HF leadership in feasibility assessments and early-stage design decisions. Qualifications
Required: Doctorate degree and 3 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience; OR Required: Master’s degree and 7 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience; OR Required: Bachelor’s degree and 9 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience; OR Required: Associate’s degree and 12 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience; OR Required: High school diploma / GED and 14 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience Required: Minimum of 3 years of direct people management and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above. Preferred: Advanced degree in Human Factors Engineering, Industrial Design, Psychology, Biomedical Engineering, or related discipline. Preferred: Experience in medical devices, combination products, or regulated healthcare environments. Preferred: Deep knowledge of FDA human factors guidance, ISO 62366, ISO 14971, MDR, and design controls. Preferred: Proven experience leading formative and summative studies supporting regulatory submissions. Preferred: Expertise integrating human factors and usability engineering with risk management and quality systems. Preferred: Strong communication skills, including regulatory documentation and executive presentations. Preferred: Experience managing external research vendors and usability testing partners.
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Associate Director, Human Factors & Usability Engineering (HF/UE) provides strategic and operational leadership for the integration of human factors, usability, and user-centered risk management across Amgen’s product portfolio. This role ensures human factors and usability principles are embedded throughout the product lifecycle—from early concept development through post-market surveillance—to deliver safe, effective, and intuitive products for patients, caregivers, and healthcare professionals. Responsibilities
Lead, develop, and mentor a high-performing human factors and usability engineering team. Build enterprise capability in human factors and usability by establishing scalable processes, tools, and best practices. Champion the integration of human factors, usability, and user-centered design into product development processes. Define and drive HF/UE strategy aligned with regulatory requirements, development milestones, and quality systems. Oversee planning and execution of formative and summative human factors studies in alignment with FDA, EMA, MDR, ISO 62366, and global standards. Ensure seamless integration of HF/UE activities within design controls and risk management (ISO 14971). Author and review HF/UE documentation including plans, use-related risk analyses, validation protocols, reports, and regulatory responses. Integrate use-related risk management across the product lifecycle to minimize on-market risk. Collaborate cross-functionally with Device Engineering, Regulatory Affairs, Quality, Medical, Packaging, Manufacturing, and Operations teams. Provide HF leadership in feasibility assessments and early-stage design decisions. Qualifications
Required: Doctorate degree and 3 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience; OR Required: Master’s degree and 7 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience; OR Required: Bachelor’s degree and 9 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience; OR Required: Associate’s degree and 12 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience; OR Required: High school diploma / GED and 14 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience Required: Minimum of 3 years of direct people management and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above. Preferred: Advanced degree in Human Factors Engineering, Industrial Design, Psychology, Biomedical Engineering, or related discipline. Preferred: Experience in medical devices, combination products, or regulated healthcare environments. Preferred: Deep knowledge of FDA human factors guidance, ISO 62366, ISO 14971, MDR, and design controls. Preferred: Proven experience leading formative and summative studies supporting regulatory submissions. Preferred: Expertise integrating human factors and usability engineering with risk management and quality systems. Preferred: Strong communication skills, including regulatory documentation and executive presentations. Preferred: Experience managing external research vendors and usability testing partners.
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