Senior Human Factors Engineer HFE Usability Engineering UE
Senior Human Factors Engineer HFE Usability Engineering UE
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$ 166594 - 166594
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Job Description
Career Category
EngineeringJob Description
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. 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 awardwinning 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.
Senior Human Factors Engineer (HFE) / Usability Engineering (UE)
What you will do
Lets do this! Lets 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 biopharmaceutical 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 Amgens portfolio or programs.
Leading usability activities such as study planning/coordination/management protocol development study moderation data collection material development IRB submissions participant recruitment
To lead usability data analysis and HFE design history file documentation to support project needs.
Collaborate with the senior HFE team members to ensure humansystem 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.
Lead appropriate human factors and usability engineering activities to improve the design of products specifically the deviceuser 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.
Leading and/or supporting HF Lead in 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. Remote work may be considered.
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 10 years of Human Factors Engineering/Usability Engineering experience OR
Associates degree and 8 years of Human Factors Engineering/Usability Engineering experience OR
Bachelors degree and 4 years of Human Factors Engineering/Usability Engineering experience OR
Masters degree and 2 years of Human Factors Engineering/Usability Engineering experience OR
Doctorate degree
Preferred Qualifications:
Medical device combination product noncombination 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 partsand 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 and Biological Products General Device Labeling 21 CFR Part 801 Use of Symbols 21 CFR Part 801.15
Masters degree in Human Factors Engineering (HFE) Usability Engineering Biomedical or Systems Engineering and 5 years of industry experience medical devices or combination products noncombination product including large and small molecule products working in a matrixed and fastpaced corporation.
Experience in frontend 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 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 requiresexcellentoral 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 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 wellbeing. 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 salesbased incentive plan
Stockbased longterm incentives
Awardwinning timeoff plans
Flexible work models including remote and hybrid work arrangements where possible
Apply now and make a lasting impact with the Amgen team.
In any materials you submit you may redact or remove ageidentifying 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.
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. Amgen is an Equal Opportunity employer and will consider you without regard to your race color religion sex sexual orientation gender identity national origin protected veteran status or disability status.
.Salary Range
133270.00 USD 166594.00 USDRequired Experience:
Senior IC
Employment Type
Full-Time
