Human Factors Engineer – Onsite (JP14073)

3 Key Consulting•Thousand Oaks, CA

13d•Onsite

About The Position

This is expected to be a contract position within the Human Factors and Usability Engineering group, working 40 hours/week. The position is for 1 year; it may be renewed at the end of that period. Ideally, candidates are local and work in-person in Thousand Oaks, CA. Exceptional candidate with successful experience working remotely may be considered. Due to the prototype build responsibilities, this role is in-person only in Thousand Oaks, CA. 3 Key Consulting is hiring a Senior Human Factors Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company. 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.

Requirements

Minimum 4-6 years of experience reviewing documents including medical device IFUs.
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.
Medical, healthcare, medical devices and/or pharmaceuticals background.
High-level attention to detail and accuracy in reducing errors in work deliverables.
Punctual, reliable, flexible, and excellent at balancing multiple detail-oriented projects.
Strong organization and communication skills.

Nice To Haves

Knowledge of Microsoft Access and Visio is a plus.

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.
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.