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

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