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The 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.
Job Responsibility:
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
Requirements:
Doctorate degree and 3 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience
Master’s degree and 7 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience
Bachelor’s degree and 9 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience
Associate’s degree and 12 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience
High school diploma / GED and 14 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience
Minimum of 3 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
Nice to have:
Advanced degree in Human Factors Engineering, Industrial Design, Psychology, Biomedical Engineering, or related discipline
Experience in medical devices, combination products, or regulated healthcare environments
Deep knowledge of FDA human factors guidance, ISO 62366, ISO 14971, MDR, and design controls
Proven experience leading formative and summative studies supporting regulatory submissions
Expertise integrating human factors and usability engineering with risk management and quality systems
Strong communication skills, including regulatory documentation and executive presentations
Experience managing external research vendors and usability testing partners
What we offer:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan