Associate Director Engineering

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.