Senior Human Factors Engineer

Career Category Engineering Job Description 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. 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. Senior Human Factors Engineer What you will do Let’s do this! Let’s change the world! In this vital role you are responsible for leading HFE/UE planning, research, development, and continuous improvement of Amgen drug delivery devices using HFE/UE best practices and in accordance with current regulations and guidelines within the medical device, combination product and bio-pharmaceutical industries. The Senior Human Factors / Usability Engineer is a thought leader and user advocate both within the HF groups and to external teams. You will be a key stakeholder and collaborate with internal and external partners and across functions within marketing, engineering, risk, quality, safety, manufacturing, and regulatory teams. Our function is to design and implement human factors research to drive innovative and intuitive products. You will lead project study design, methodology, data collection, root cause analysis to inform design. You will support human factors and usability engineering activities to ensure the product user interface design of Amgen’s products support safe and effective use. Role Responsibilities: The Sr. HFE/UE responsibilities include but are not limited to: Partner cross-functionally with engineering, operations, regulatory, risk, quality, clinical, drug product, digital health, commercial to ensure Amgen products are safe and effective for end users. Lead and support human factors and usability engineering activities to improve the design of products, specifically the device-user interface. This includes the device, packaging, labeling, and instructions for use. Develop, strategize, and implement a risk-prioritized, fit-for-purpose approach to HF activities. Ensure human-system capabilities and limitations are accurately reflected in the system requirements, and HFE/UE input is provided across functions to develop device design, packaging, labeling, and training requirements. Identify, lead, and support appropriate human factors and usability engineering activities to improve the design of device-user interfaces, including the device, packaging, labeling, and instructions for use to minimize the potential for use errors. Analyze objective and subjective data from usability studies to inform product design, identify and mitigate use-risk, and provide robust solutions. Lead the design and execution of human factors formative and summative activities, including moderation, note taking, vendor engagement, and analysis of data. Support and provide HFE expertise in preparation for clinical studies and regulatory submissions in accordance with HF best practices, guidance and standards. Create documentation to support development activities, design controls, DHF, DMR including protocols, task analysis, use-related risk analysis (URRA), usability technical assessments, HF validation reports, and regulatory submissions. Clearly and actively communicate regularly with key internal and external partners. This position may require up to 20% yearly travel mostly local and domestic. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The highly organized professional we seek is a problem solver and has the requisite training and experience to be an effective contributor and team members. Basic Qualifications: Doctorate degree OR Master's degree and 2 years of Human Factors Engineering/Usability Engineering experience in the Biomedical/Pharmaceutical/Medical Device Field OR Bachelor's degree and 4 years of Human Factors Engineering/Usability Engineering experience in the Biomedical/Pharmaceutical/Medical Device Field OR Associate's degree and 8 years of Human Factors Engineering/Usability Engineering experience in the Biomedical/Pharmaceutical/Medical Device Field OR High school diploma/GED and 10 years of Human Factors Engineering/Usability Engineering experience in the Biomedical/Pharmaceutical/Medical Device Field Preferred Qualifications: Bachelor’s or Master's degree in Human Factors, Usability Engineering, or other relevant Psychology, Industrial Design or Engineering discipline and 5-7 years of industry experience, working in multi-functional, fast-paced corporate environments. HF experience in the design and manufacturing of injectable devices (e.g., auto-injectors, pens, needle-free injectors, syringes) or devices for non-invasive/minimally invasive drug delivery systems (e.g., pulmonary, transdermal). HFE/UE experience planning, coordinating, conducting, analyzing, reporting human factors studies without vendor support. Experience with various HF methodologies such as ethnographic research, interviews, contextual inquiries, focus groups, technical assessments, device UI evaluation, knowledge and comprehension studies, HF professional analysis, task analysis, hazard analysis, risk assessment, formative and summative studies. Experience working directly with users to gather, synthesize and convert user research into concepts that differentiate products in the market, as well as to develop and evaluate new product features, user interfaces and ergonomic designs. Experience using low and high fidelity prototypes to identify and eliminate potential use errors early in the development process. Experience working in development organizations, particularly virtual development environments. Experience working within the development of systems design, verification, and validation. Functional knowledge and experience in the practical application of relevant FDA human factors guidance, regulations and standards, including IEC 62366, AAMI HE75, EN 60601-1-6, ISO 14971, MDR, and design controls. What you can expect from 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, we’ll 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. 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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. . Salary Range 129,369.15USD -175,028.85 USD