Career Category

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
• 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 OR
• 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 OR
• 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 OR
• 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 or related experience in medical device/combination products or healthcare

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 (written and verbal), the ability to work in teams, the ability to adapt to a rapidly changing environment, and the ability to lead internal designers and external design consultants
• 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 (InDesign, Illustrator, Photoshop) and preparing artwork for printing
• 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: FDA’s Human Factors Guidance’s, 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, 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
• 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