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Associate Director Engineering

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Amgen

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Location:
United States , Thousand Oaks

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Category:
-

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Contract Type:
Not provided

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Salary:

180131.00 - 212768.00 USD / Year

Job Description:

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
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible

Additional Information:

Job Posted:
March 20, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
Job Link Share:

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