Amgen Sr. Manager - Human Factors and Instructional Design
The Sr. Manager - Human Factors and Instructional Design is responsible for defining the requirements and designing and developing instructions for use --content, form factors, information architecture, typography, illustrations, and layout—to promote safe and effective use of Amgen products globally.
S/he will work closely with HF engineers, instructional designers, and cross-functional development teams to understand the user needs for the different users of Amgen products, including patients, caregivers, and Health Care Providers (HCPs: nurses, physicians, and pharmacists). S/he will use insights, user needs, preliminary HF analyses, task analyses, use-related risk analyses, and formative testing as inputs into design and development of the instructional materials to support safe and effective use of the product for the intended use by the intended users in the anticipated use environment.
This leadership role requires careful assessment and balance of competing priority inputs of best-practice instructional design, internal requirements, manufacturing constraints, and global regulatory requirements with overall simplicity to support effective use by intended users of Amgen products. This role requires application of good Human Factors and Human-Centered Design methods to drive transformational innovation and ensure "the right product the first time" to support Amgen's mission to serve patients.
The Sr. Manager - Human Factors (HF) and Instructional Design (INST) responsibilities include but are not limited to:
•Define requirements, ideate, design, iterate and refine/develop instructions to enable patients, caregivers, and HCPs to safely and effectively use Amgen products. Primary instruction types will include: Instructions for Use (IFU), Quick Reference Guide (QRG), USPI, MedGuide, clinical instructions, and other product labeling. Supplemental instruction types may include: digital training tools, digital IFUs, support for video training, and other ancillary training tools. •Collaborate closely with Human Factors and Usability Engineering staff in the requirements definition, design, testing with users, and design iterations to quickly and effectively develop effective instructions. •Work with other Amgen internal stakeholders—including Global Commercial Innovation, Packaging Engineering, Commercial brand teams, Usability Engineering, Regulatory, Safety, Labeling, and Artwork Center—to ensure the various design inputs are understood and incorporated into the instructions. •Analyze objective and subjective data from usability studies and complaints data to inform instruction design. •Prepare documentation to support development activities, design controls, DHF, UEF including protocols, task analysis, risk assessment, HFE technical assessments, HFE reports, and regulatory submissions. •Design instructions fit for purpose for early stage feasibility and development phases, to support a rapid test-and-learn iterative design process. Attend HF Testing sessions with other HF engineers and instruction designers to observe and quickly understand user behaviors identify causality of use errors, and work to quickly solve new challenges with changes to the instructions. •Working with HF Instruction Designers, HF engineers, Regulatory/Labeling, and Artwork Center, define and develop instructional style guides and platform templates that can guide consistency across Amgen products and can be leveraged for future products. •Actively communicate with internal and external key stakeholders.
This position requires up to 25% yearly travel mostly local and domestic.
Doctorate degree and 2 years of Human Factors Engineering, Usability Engineering, or Engineering in medical device or biotech industry
Master's degree and 6 years of Human Factors Engineering, Usability Engineering, or Engineering in medical device or biotech industry
Bachelor's degree and 8 years of Human Factors Engineering, Usability Engineering, or Engineering in medical device or biotech industry
Associate's degree and 10 years of Human Factors Engineering, Usability Engineering, or Engineering in medical device or biotech industry
High school diploma / GED and 12 years of Human Factors Engineering, Usability Engineering, or Engineering in medical device or biotech industry
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
•Masters degree in Human Factors Engineering (HFE), Usability Engineering, Medical Device, Mechanical Engineering, Biomedical or Systems Engineering and 10+ years of business experience, medical devices or combination products, working in cross functional, 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 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 converse technically with mechanical, electronic, 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 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. •Subject matter expert of principles and industry application of Medical Device and healthcare regulations 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 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
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.
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