Senior Human Factors Instructional Designer
The Senior Human Factors Instructional Designer is responsible for the design and development of instructions--content, form factors, information architecture, typography, illustrations, and layout-to promote safe and effective use of Amgen products for users around the world. The Senior Designer develops instructions (as part of medical product labeling) based upon best practices, usability study results and design iterations, and industry standards. The role involves balancing effective visual communication design, iterative design processes, regulatory and internal requirements, and manufacturing constraints to guide and instruct patients and Health Care Providers (HCPs) to safely and effectively use our products. This role will apply Design Thinking 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. HF Instructional Designer responsibilities include but are not limited to:
- Design, iterate and 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 Guides (QRGs), USPI, MedGuide, clinical instructions, and other product labeling. Secondary 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 design, testing with users, and design iterations to quickly and effectively develop effective instructions.
- Work with other Amgen internal stakeholders-including Customer Experience, Packaging Engineering, Commercial brand teams, Usability Engineering, Labeling, Artwork Center-to ensure the various design inputs are understood and incorporated into the instructions.
- Create (hands-on) instruction illustrations, focusing on line-art of hands interacting with medical devices. Create (hands-on) print-based and digital layouts of instructions that meet the needs of the users in different product use cases.
- Manage design changes and the development and delivery of final artwork to the appropriate internal stakeholders. Work closely with Usability Engineers to clearly track changes made to instructions with user testing results.
- Design instructions appropriate for the development stage, to support a rapid test-and-learn iterative design process. For example, fast and simple block layouts and placeholders for illustrations and copy for initial concepts and testing with users; refinements made for testing for mid-stage concepts; fine-tuned layout, typography, illustrations, and copy for final instruction designs for delivery.
- Define and develop instructional style guides and platform templates that can guide consistency across Amgen products and can be leveraged for future products.
- Develop innovative approaches for simplifying and explaining complex information and tasks.
- Participate in planning, organizing, and executing other visual information production projects for the Human Factors and Usability Engineering team.
- Verify labeling against input documents and labeling artwork that convey effective visual design of typography, graphics and space to maximize visual impact and to emphasize safe and effective use of the combination product.
- Maintain compliance with relevant standards and regulations in performing the duties associated with this role in accordance with standards/procedures, training curriculums, continuous improvement initiatives, and routing and approval of assigned labeling deliverables Change control and documentation processes.
This position requires approximately 20% yearly travel, mostly local and domestic.
Master's degree and 3 years of Instructional Design, Graphic Design, Visual Design, User Experience Design (UxD), User Interface (UI) Design, Labeling Design, Content Development
Bachelor's degree and 5 years of Instructional Design, Graphic Design, Visual Design, User Experience Design (UxD), User Interface (UI) Design, Labeling Design, Content Development
Associate's degree and 10 years of Instructional Design, Graphic Design, Visual Design, User Experience Design (UxD), User Interface (UI) Design, Labeling Design, Content Development
High school diploma/GED and 12 years of Instructional Design, Graphic Design, Visual Design, User Experience Design (UxD), User Interface (UI) Design, Labeling Design, Content Development
Preferred Qualifications: -
- 8+ years of creating, designing, and developing instructions and labeling, for medical devices or combination (medical) products in medical device/combination products or healthcare company
- Knowledge of relevant Human Factors and Usability regulations, standards and guidance for medical devices and pharmaceutical packaging
- Experience conceptualizing and/or designing instructional documents, in concert with the design of packaging and medical devices themselves
- Excellence in visual design to promote quick and easy identification of essential information, proper flow of information, critical information to perform tasks while framing expectations to facilitate use, promote understanding and lessen the cognitive burden on users
- Strong graphic design, page layout, illustration, typography, and instructional design skills
- Advanced proficiency with Adobe Creative Suite (InDesign, Illustrator, Photoshop) and preparing artwork for printing
- Experience with brand design and print production
- Able to translate complex product information into concise, compliant, easy-to-follow instructions for use
- Experience with Usability Engineering in the medical, pharmaceutical, and/or healthcare industry
- Excellent skills in Microsoft Word, Excel, PowerPoint, and Outlook
- Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering disciplines
- Experience working directly with users (patients and HCPs) to develop and evaluate new product features, user interfaces and ergonomic designs elevating the overall user experience
- 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, ISO 14971, ISO 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
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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.