Top 3 Must Have Skill Sets:
8+ years of creating, designing, and developing instructions and labeling, for medical devices or combination (medical) products
Experience developing design guides and standards for corporate environments
Experience conceptualizing and/or designing instructional documents, in concert with the design of packaging and medical devices themselves
Knowledge of relevant Human Factors and Usability regulations, standards and guidance for medical devices and pharmaceutical packaging
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 required
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
Day to Day Responsibilities:
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, Regulatory, Usability Engineering, Labeling, Artwork Center—to ensure the various design inputs are understood and incorporated into the instructions.
Interact with outside instruction and industrial design vendors to ensure progress on important instruction design workstreams.
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.
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.
REQUIRED: Please include a portfolio (pdf attachment format) of your work showing examples of instruction materials you have created, contributed to, or managed.
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 oversees vendors who develop instructions (as part of medical product labeling)--using industry best-practices and standards. The contract Senior Designer will leverage usability study results into design iterations, while also building and maintaining instruction design standards for use across the company. The role involves balancing management of vendor/partners, 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.
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 or related experience in medical device/combination products or healthcare
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 or related experience in medical device/combination products or healthcare
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 or related experience in medical device/combination products or healthcare
"This posting is for Contingent Worker, not an FTE"