Human Factors Engineer (HFE) / Usability Engineer (UE)

Career Category

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. 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.

Human Factors Engineer (HFE) / Usability Engineer

What you will do

Let’s do this! Let’s change the world!

The Human Factors Engineer (HFE) /Usability Engineer (UE) is responsible for supporting HFE/UE planning, research, development 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.

This person is expected to collaborate with internal and external partners and across functions with engineering, design, commercial, quality, and regulatory teams. This person will support human factors research driving innovative, intuitive, and useful products.

The HFE will support project study design, HF/UE methodology, study moderation, data collection, root cause analysis to inform design and apply sound HFE/UE knowledge and experience to research, development, clinical studies, and product validation in support of regulatory submissions.

Responsibilities

The HFE/UE responsibilities include but are not limited to:

• Work collaboratively with HFE, engineering, design, commercial, and product teams to ensure successful translation of user requirements into products, to create user interface (UI) requirements, that meet the needs of users and enrich the overall user experience across Amgen’s portfolio or programs.

• Supporting usability activities such as study planning/coordination/management, protocol development, study moderation, data collection, material development, IRB submissions, participant recruitment, data analysis, and HFE design history file documentation to support project needs.

• Collaborate with the HFE lead to ensure Human-system capabilities and limitations are properly reflected in the system requirements, and HFE/UE input is provided across functions to develop product design, packaging, labeling, and training requirements.

• Support appropriate human factors and usability engineering activities to improve the design of products, specifically the device-user interfaces, including the device, packaging, labeling, and instructions for use while minimizing the potential for use errors.

• Analyze objective and subjective data from usability studies to inform design, inform risk minimization, and provide alternative design controls/solutions.

• Support the HFE lead in providing preparation for clinical studies and regulatory submissions in accordance with HF best practices, guidance and standards.

• Prepare documentation to support development activities, design controls, DHF, DMR including protocols, task analysis, risk assessment, HFE technical assessments, comparative analysis, HFE reports, data verification, and regulatory submissions.

• Actively communicate with internal and external key stakeholders. Exercising critical thinking & educated HFE judgement to determine appropriate next steps/actions.

This position requires up to 20% yearly local and domestic travel.

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 an individual with these qualifications.

Basic Qualifications:

• High school diploma / GED and 8 years of Human Factors Engineering/Usability Engineering experience OR

• Associate’s degree and 6 years of Human Factors Engineering/Usability Engineering experience OR

• Bachelor’s degree and 2 years of Human Factors Engineering/Usability Engineering experience OR

• Master’s degree

Preferred Qualifications:

• Medical device, combination product, non-combination product including small and large molecule experience including functional knowledge of applicable guidance, regulations and standards including: ISO 14971, ICH Q9, ICH Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211, Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers, Design Considerations for Devices Intended for Home Use, Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development, Draft Guidance for Industry List of Highest Priority Devices for Human Factors Review, Applying Human Factors and Usability Engineering to Medical Devices, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products, General Device Labeling - 21 CFR Part 801, Use of Symbols - 21 CFR Part 801.15

• Master's degree in Human Factors Engineering (HFE), Usability Engineering, Biomedical or Systems Engineering and 3+ years of industry experience, medical devices or combination products, non-combination product including large and small molecule products working in a matrixed and fast-paced corporation.

• Experience in front-end feasibility phase, exploratory research, user needs translation, ideation concept evaluations, device user interface evaluations, iterative design process, requirements and specification development, risk assessments, and formative testing.

• Experience supporting or leading various HF methodologies such as planning, coordinating, conducting, analyzing and reporting ethnographic research, interviews, contextual inquiries, use scenarios, focus groups, technical assessments, device UI evaluation, knowledge and comprehension studies, expert analysis, task analysis, hazard analysis, risk assessment, formative study and summative studies.

• Ability to communicate effectively with mechanical, electrical, software, clinical, regulatory, and quality engineering disciplines.

• Experience working directly with users to develop and evaluate new product features, user interfaces and ergonomic designs elevating the overall user experience.

• The position requires good oral and written communication and organizational skills, technical problem solving, the ability to work in teams, critical thinking, the ability to adapt to a rapidly changing environment, and desire to contribute to meaningful and innovative products.

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, 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, including remote and hybrid work arrangements, where possible

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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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.

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