Associate Director Engineering

Career Category Engineering Job Description Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll 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 Lets do this! Lets 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 Amgens product portfolio. This role ensures human factors and usability principles are embedded throughout the product lifecyclefrom early concept development through post-market surveillanceto deliver safe, effective, and intuitive products for patients, caregivers, and healthcare professionals. Key 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. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree and 3 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience OR Masters degree and 7 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience OR Bachelors degree and 9 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, or related experience OR Associates 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 Preferred Qualifications 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 you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: 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. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 180,131.00 USD - 212,768.00 USD Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen