Engineer- Human Factors Engineer Usability Engineer (HF UE)

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Engineer- Human Factors Engineer / Usability Engineer (HF/ UE)

What you will do

Lets do this! Lets change the world! In this vital role you are responsible for supporting 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 Human Factors Engineer / Usability Engineer (HFE/UE) is expected to collaborate with internal and external partners and across functions including engineering design commercial safety risk quality regulatory and market surveillance teams. This person will support human factors research driving innovative intuitive and useful products. The HFE will support project study design HFE/UE methodology study moderation data collection and 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/UE 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 Amgens 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/UE design history file documentation to support project needs.

• Collaborate with the HFE/UE 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/UE lead in providing preparation for clinical studies and regulatory submissions in accordance with HFE/UE best practices guidance and standards.

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

• Actively communicate with internal and external key stakeholders. Exercising critical thinking & educated HFE/UE 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 highly organized professional we seek is a problem solver and has the requisite training and experience to be an effective contributor and team member.

Basic Qualifications:

• Masters degree in Human Factors Engineering Usability Engineering or related Psychology and/or Industrial Design domains OR

• Bachelors degree and 2 years of experience working in the regulated medical device and/or biotech industry OR

• Associates degree and 6 years of experience working in the regulated medical device and/or biotech industry OR

• High school diploma / GED and 8 years of experience working in the regulated medical device and/or biotech industry

Preferred Qualifications:

• Masters degree in Human Factors HFE/Usability Engineering or other relevant HF/Engineering discipline and 2 years of industry experience working in multi-functional fast-paced corporate environments.

• 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 contributing to systems design verification and validation milestones.

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

• 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.

• 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.

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 well 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.

Salary Range