3 Key Consulting, Inc. · 5 months ago
Human Factors Engineer, Biopharma Drug Delivery Device IFUs (JP14418)
3 Key Consulting, Inc. is hiring a Human Factors Engineer for a consulting engagement with a leading global biopharmaceutical company. The role involves supporting the Instruction Design and Human Factors Engineering teams by reviewing and documenting instruction materials for drug delivery devices, ensuring accuracy and maintaining change history during the development process.
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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
Qualification
Required
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
Benefits
Benefits
Company
3 Key Consulting, Inc.
3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries.
H1B Sponsorship
3 Key Consulting, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (6)
Funding
Current Stage
Growth StageRecent News
2025-09-29
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