Human Factors Engineer, Biopharma Drug Delivery Device IFUs; JP

Human Factors Engineer, Biopharma Drug Delivery Device IFUs

Supports the Instruction Design and Human Factors Engineering/Usability Engineering (HFE) teams to document and accurately review and check instruction materials, including Instructions for Use (IFUs) that are used to instruct laypersons in the proper use of combination products/drug delivery devices. Materials to review will include content copy, layout, line-art illustrations, and other graphical elements for IFUs, carton artwork, and device labeling.

Works closely with other designers, HF engineers, and other artwork functions. In addition to accuracy, role requires instruction checks with quick turnarounds during instruction development to support iterative usability study timelines in a design-test-refine-test model. Maintains history records of changes to instruction materials to capture rationale for those changes over the development process. Supports process improvement initiatives, including defining and documenting current procedures within the group and working with cross-functional partners to improve and document labeling across upstream and downstream functions.

Top Must Have

Skills:

• Minimum 4-6 years of experience reviewing documents including medical device IFUs., including strong proficiency in rapid sketch illustration, digital line-art illustration, and image (photo) editing.
• 2-4 years' experience using Adobe Creative Suite software (InDesign and Illustrator) and Microsoft Word and Excel. Knowledge of Microsoft Access and Visio is a plus.
• High-level attention to detail and accuracy in reducing errors in work deliverables.
• Medical, healthcare, medical devices and/or pharmaceuticals background.
• Must be punctual, reliable, flexible, and excellent at balancing multiple detail-oriented projects. Strong organization and communication skills.

Day to Day Responsibilities:

• Review new and updated IFUs, reference guides, and carton artwork content and graphics (layout and illustrations) for medical device/combination products to ensure accuracy. Some reviews will use digital comparison tools; other reviews will require manual checking.
• Maintain change history of instruction materials during their development, including changes from regulatory authorities and Human Factors studies.
• Ensure changes to specific projects are communicated to other programs for implementation.
• Support extension of department platform designs into individual projects. Communicate daily with other designers on impact to platform designs, and update platforms as appropriate.
• Develop instruction design strategies for individual projects that align with department and corporate instruction platforms. Manage individual projects, representing the Instruction Design group, by coordinating with cross-functional teams (including Human Factors, Device Engineering, Marketing Labeling, Clinical, Legal and Regulatory Affairs) to define instructional requirements and execute on plans.
• Support process improvement programs and documentation as it relates to design and development processes.

Employee Value Proposition:

• Career growth
• Networking
• Unique industry experience

Red Flags:

• Review experience with text-based instructions only (ex., SOP development without illustrations and layout, personnel training manuals, defense user manuals). This role needs applicants with experience reviewing graphics as well as copy.
• Only has checking experience; role requires ability to contribute to improving processes involving design and checks.

Interview process:

• To be considered, candidates MUST supply an online portfolio
• TEAMs/ video conference panel