Senior Human Factors Engineer

Amgen Inc.; Cambridge (MA); On-site; USD 129,000 - 175,000; Full time

Job summary

Amgen is seeking a Senior Human Factors Engineer to lead HFE/UE planning, research, and continuous improvement of drug delivery devices. You will partner with engineering, regulatory, quality, and manufacturing teams to ensure safe, effective device interfaces and user-centered design processes.

In this role you will design formative and summative studies, develop URRA analyses, and prepare documentation for regulatory submissions while guiding cross-functional teams toward risk-based,

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

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.
• 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.

Job description

Career Category

Operations

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity‑related conditions, rare diseases, inflammatory conditions and cancer. 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

Let’s do this! Let’s change the world! In this vital role you will be 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 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.

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., autoinjectors, 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.
• 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.

• 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.

Salary Range

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.

129.369,15USD -175.028,85 USD

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 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.

Equal Opportunity Employer

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.