Associate Director Engineering

Amgen • Cambridge, MA

3d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Associate Director Engineering What you will do Let’s do this! Let’s change the world! 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.

Requirements

• Doctorate degree and 3 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience OR Master’s degree and 7 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience OR Bachelor’s degree and 9 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience OR Associate’s degree and 12 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience OR High school diploma / GED and 14 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience
• In addition to meeting at least one of the above requirements, you must have a minimum of 3 years’ experience directly managing people 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

Nice To Haves

• 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.

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director