Amgen is seeking an Associate Director Engineering to lead human factors and usability engineering teams, providing strategic and operational leadership for the integration of human factors, usability, and user-centered risk management across Amgen’s product portfolio.
Requirements
- 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
Benefits
- Comprehensive employee benefits package
- Discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models
- Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
