Senior Human Factors Engineer - Usability

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. 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. Engineer – Senior Human Factors Engineer / Usability Engineer (HF/ UE) 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.

Requirements

• Doctorate 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

Nice To Haves

• Bachelor’s or Master's degree in Human Factors, HFE/Usability Engineering, or other relevant HF/Engineering discipline and 5-10 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, ISO 14971, MDR, and design controls.

Responsibilities

• 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 requires up to 20% yearly travel mostly local and domestic.

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: Mid Level