25 days old

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

Amgen
Thousand Oaks, CA 91360
  • Job Code
    115509490
Amgen

Job ID: R-87221
Location: Thousand Oaks, CA, US 91360

The Human Factors Engineer (HFE) /Usability Engineer (UE) shall contribute to and facilitate HFE/UE research, development and continuous improvement activities of Amgen drug delivery devices using HF/UE best practices and in accordance with current regulations and guidelines within the medical device, combination product and bio-pharmaceutical industries. HFE/UE collaborates with internal and external partners and across functions with marketing, engineering, quality, manufacturing, and regulatory teams. Implement human factors research to drive innovative and intuitive products.HFE will 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.Responsibilities include:
  • Manage HF aspects of project including: planning, timelines, milestones, deliverables, resources, priorities and budget requirements.
  • Plan, conduct, analyze and report human factors activities supporting multiple projects.
  • Assist in defining user needs, translation of needs into measurable specifications, evaluation of device-user interfaces, usability studies throughout Research & Development and Life Cycle Management phases.
  • Ensure HFE/UE/ID input is provided across functions to develop device design, packaging, labeling, and training requirements.
  • Ensurebrand driven aesthetics are applied consistently across the entire product portfolio.
  • Support usability testing such as planning, protocol development, data collection sheets, moderator scripts, material development, study coordination, IRB submissions, managing participant recruitment, study management, data collection, analysis, and documentation to support project needs.
  • Assist in preparation for clinical studies and regulatory submissions in accordance with HF best practices.
  • Analyze objective and subjective data from usability studies to inform design and provide alternative solutions.
  • Active communication with internal and external key stakeholders.
  • Prepare documentation to support development activities, design controls, DHF, DMR including protocols, task analysis, risk assessment, and HFE reports.


This position requires up to 25% yearly travel mostly local and domestic.

Basic Qualifications:

Master's degree
OR
Bachelor's degree and 2 years of Engineering, Operationsor Industrial Design experience
OR
Associate's degree and 6 years of Engineering, Operationsor Industrial Design experience
OR
High school diploma / GED and 8 years of Engineering, Operationsor Industrial Design experience

Preferred Qualifications :
  • Master's degree in Human Factors, HFE/Usability Engineering, Medical Device, Mechanical Engineering, Industrial Design, Biomedical or Systems Engineering and 2+ years of business experience, working in cross functional, fast-paced corporation.
  • Combination product experience including functional knowledge of applicable guidance, regulations and standards including: FDA's Human Factors Guidance, Labeling for home use, 14971, 62366. HE 75, EU Annex 1, 21 CFR parts 4, 820, 210 and 211, MHRA HF Guidance, FDAs Quality System Regulation (QSR), ISO 13485, EN 60601, Council Directive 93/42/EEC, 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 IndustryList 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, GeneralDevice Labeling - 21 CFR Part 801, Use of Symbols - 21 CFR Part 801.1
  • HFE/UE experience planning, coordinating, conducting, analyzing, reporting formative human factors studies without vendor support.
  • Experience with various HF methodologies such as 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.
  • Experience in the front-end user needs identification, task analysis, URRA, specification development, risk assessments, testing, verification and validation.
  • The position requires strong 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.
  • Self-motivated and able to work independently with limited supervision, making informed decisions based on analysis
  • Skills in Microsoft Word, Excel, PowerPoint, and Outlook.


Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.

PI115509490

<b>Amgen</b><br/><br/><b>Job ID: </b>R-87221<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The Human Factors Engineer (HFE) /Usability Engineer (UE) shall contribute to and facilitate HFE/UE research, development and continuous improvement activities of Amgen drug delivery devices using HF/UE best practices and in accordance with current regulations and guidelines within the medical device, combination product and bio-pharmaceutical industries. HFE/UE collaborates with internal and external partners and across functions with marketing, engineering, quality, manufacturing, and regulatory teams. Implement human factors research to drive innovative and intuitive products.HFE will 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.Responsibilities include:<br><ul><li>Manage HF aspects of project including: planning, timelines, milestones, deliverables, resources, priorities and budget requirements.</li><li>Plan, conduct, analyze and report human factors activities supporting multiple projects.</li><li>Assist in defining user needs, translation of needs into measurable specifications, evaluation of device-user interfaces, usability studies throughout Research & Development and Life Cycle Management phases.</li><li>Ensure HFE/UE/ID input is provided across functions to develop device design, packaging, labeling, and training requirements.</li><li>Ensurebrand driven aesthetics are applied consistently across the entire product portfolio.</li><li>Support usability testing such as planning, protocol development, data collection sheets, moderator scripts, material development, study coordination, IRB submissions, managing participant recruitment, study management, data collection, analysis, and documentation to support project needs.</li><li>Assist in preparation for clinical studies and regulatory submissions in accordance with HF best practices.</li><li>Analyze objective and subjective data from usability studies to inform design and provide alternative solutions.</li><li>Active communication with internal and external key stakeholders.</li><li>Prepare documentation to support development activities, design controls, DHF, DMR including protocols, task analysis, risk assessment, and HFE reports.</li></ul><br><br>This position requires up to 25% yearly travel mostly local and domestic.<br><br><b> Basic Qualifications: </b><br><br>Master's degree<br>OR<br>Bachelor's degree and 2 years of Engineering, Operationsor Industrial Design experience<br>OR<br>Associate's degree and 6 years of Engineering, Operationsor Industrial Design experience<br>OR<br>High school diploma / GED and 8 years of Engineering, Operationsor Industrial Design experience<br><br><b> Preferred Qualifications </b>:<br><ul><li>Master's degree in Human Factors, HFE/Usability Engineering, Medical Device, Mechanical Engineering, Industrial Design, Biomedical or Systems Engineering and 2+ years of business experience, working in cross functional, fast-paced corporation.</li><li>Combination product experience including functional knowledge of applicable guidance, regulations and standards including: FDA's Human Factors Guidance, Labeling for home use, 14971, 62366. HE 75, EU Annex 1, 21 CFR parts 4, 820, 210 and 211, MHRA HF Guidance, FDAs Quality System Regulation (QSR), ISO 13485, EN 60601, Council Directive 93/42/EEC, 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 IndustryList 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, GeneralDevice Labeling - 21 CFR Part 801, Use of Symbols - 21 CFR Part 801.1</li><li>HFE/UE experience planning, coordinating, conducting, analyzing, reporting formative human factors studies without vendor support.</li><li>Experience with various HF methodologies such as 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.</li><li>Experience in the front-end user needs identification, task analysis, URRA, specification development, risk assessments, testing, verification and validation.</li><li>The position requires strong 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.</li><li>Self-motivated and able to work independently with limited supervision, making informed decisions based on analysis</li><li>Skills in Microsoft Word, Excel, PowerPoint, and Outlook.</li></ul><br><br>Join Us <br> <br> If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. <br> <br> Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. <br> <br> 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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. <br> <br> 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, or disability status.<br/><br/> <img src="https://analytics.click2apply.net/v/4ea1rnc4DJJ4ho6zuWPd8"> <p>PI115509490</p>

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Posted: 2019-11-15 Expires: 2019-12-16

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

Amgen
Thousand Oaks, CA 91360

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