Day to Day Responsibilities:
- Create and update IFU content and graphics (layout and illustrations) for new and existing medical device/combination products to ensure accuracy and compliance with applicable regulations, industry standards, and Company requirements
- Produces low (quick sketch) to high (refined digital files) fidelity prototypes of IFUs for usability studies.
- Collaborates with internal partners to develop production level instructional materials to support product use
- Provides expertise and guidance in the content generation, illustrations, layout, and formatting of early stage IFUs
- Coordinates with cross-functional teams (including Human Factors, Device Engineering, Marketing Labeling, Clinical, Legal and Regulatory Affairs) to define instructional requirements
- Troubleshoots relatively complex problems and issues
- Onsite M-F full time
- Supports Human Factors Engineering/ Usability Engineering, Labeling, and Device Teams to create early stage Instructions for Use (IFUs) used to instruct laypersons in the proper use of combination products/ drug delivery devices.
- IFU creation includes: content, layout, and line-art illustrations.
- Develops both low (simple sketch) and high-fidelity digital samples of instructional materials to support usability studies with quick turn-around during iterative studies. Balances design thinking with regulatory requirements while developing instructional materials.
"This posting is for Contingent Worker, not an FTE"