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| Job Title | Senior Instructional Designer/Human Factors Engine | ||
| Country | United States of America | ||
| Job Description | The Senior Instructional Designer/Human Factors Engineer will help guide instructional design activities for development of Amgen drug products, drug delivery devices and related systems, taking into consideration all aspects of the user, the intended use, the use environment, and the drug therapy being administered. The Senior Instructional Designer/Human Factors Engineer will collaborate with marketing, engineering, quality, risk management, manufacturing, and regulatory team members to create innovative and intuitive-to-use instructional and labeling materials through the application of human-centered design methodologies and human factors engineering. The Senior Instructional Designer/Human Factors Engineer will work with the Senior Manager of Instructional Design/Human Factors Engineering to collaborate with internal and external teams to assure brand driven aesthetics and user-centered design are applied consistently across the entire drug product portfolio. This person will help with planning, designing and execution of instructional design and labeling materials in support of human factors engineering studies across a variety of combination product and pharmaceutical programs according to current regulations and guidelines within the medical device and bio-pharmaceutical industries. This person will be responsible for the management of instruction digital assets and developing and maintaining traceability records for changes over the evolution of the instructions. This person will ensure that expert instructional design and human factors input are provided to development teams for the creation of design requirements, packaging requirements, training requirements and use instructions, as well as supporting design validation and clinical studies associated with regulatory submissions. The Senior Instructional Designer/Human Factors Engineer ensures: • Labeling and instructional materials meet user needs and have been designed to ensure safe and effective use; • Outputs map to user needs, context of use, task analysis and use related risk assessment documentation; • Digital assets are managed and traced throughout design-testing iterations; and • Outputs meet current US and global instructional and labeling regulatory requirements. This position requires approximately 20% yearly travel, mostly local and domestic. Basic Qualifications: • Doctorate Degree OR • Masters degree and 3 years of Instructional Design, Graphic Design, Visual Design, User Experience Design • Bachelors degree and 5 years of Instructional Design, Graphic Design, Visual Design, User Experience Design • Associates degree and 10 years of Instructional Design, Graphic Design, Visual Design, User Experience Design • High school diploma/GED and 12 years of Instructional Design, Graphic Design, Visual Design, User Experience Design Preferred Qualifications: • Master's degree in Human Factors, Human-Computer Interaction, Communication Design, or Cognitive Psychology, and 6+ years of business experience, working in development organizations • 4+ years of experience working in the development of medical device and/or pharmaceutical industries • Excellent organizational, technical problem solving, design and communication skills • 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 • Proficiency with Adobe Creative Suite • Experience managing digital files and assets, and maintaining traceability records as instruction files change during a human-centered design process • Experience working directly with customers to gather, synthesize and convert user research into concepts that differentiate products in the market • Experience working directly with customers to develop and evaluate new product features, user interfaces and ergonomic designs, and with ensuring customer satisfaction • Knowledge of relevant human factors regulations, standards and guidance for medical devices and pharmaceutical labeling and packaging • Subject matter expert of principles and industry application of Medical Device and healthcare regulations including: FDAs Human Factors Guidances, 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 • Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering disciplines • Proven experience using low- and high-fidelity prototypes to identify and eliminate potential use errors early in the development process • Demonstrated time management, decision making, presentation and organization skills 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. 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 requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff | ||