Senior Human Factors Engineer IFUs & Prototyping - Onsite (JP14072) at 3 Key Consulting Thousan

Senior Human Factors Engineer IFUs & Prototyping – Onsite (JP14072)

Location: Thousand Oaks, CA (Onsite only)

Employment Type: Contract

Business Unit: Operations Patient Experience

Duration: 1+ years (with likely extensions and/or conversion to permanent)

NOTE:

This is expected to be a contract position within the Human Factors and Usability Engineering group, working 40 hrs/week. The position is for 1 year; it may be renewed at the end of that period. Ideally, we would like candidates to be local and work in-person in Thousand Oaks, CA. Exceptional candidates with successful experience working remotely may be considered. If the candidate is within commuting distance to Thousand Oaks, they will be expected to work on‑site most/all hours.

• Supports the Instruction Design and Human Factors Engineering/Usability Engineering (HFE) teams to create instruction materials, including Instructions for Use (IFUs) used to instruct laypersons in the proper use of combination products/drug delivery devices.
• IFU creation includes copy, layout, and line‑art illustrations. Develops both low‑ (simple sketch) and high‑fidelity digital samples of instructional materials intended for print.
• Manages instruction design projects, working closely with other designers, HF engineers, and other related functions.
• Supports usability studies with quick turn‑around during iterative studies in a design‑test‑refine‑test model.
• Balances design thinking with regulatory requirements during development of instructional materials.
• Develops instructions for new projects by understanding user needs with HFE partners and applying platform guidelines to create approachable, useful, and effective instructions for users who may be new to the therapy and drug administration.
• Hand‑builds small batches of prototypes for concept development and for use in usability studies.
• Maintains history records to capture rationale for changes over the development of the instructions.
• 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.

Supplement additional workload on team/backfill

• Minimum 5‑10 years of instruction design experience including IFUs, including strong proficiency in rapid sketch illustration, digital line‑art illustration, and image (photo) editing. Proficient in Adobe Creative Suite (InDesign, Illustrator, Photoshop), and strong knowledge of InDesign paragraph and character styles. Understands the application of structure and grids for the development of platforms to ensure consistency in output and efficiency in process during instruction creation.
• Minimum 3‑5 years prototyping small volume (10‑100 pieces) cartons, leaflets, and labels for use in usability studies. Requires manual assembly and craft‑type skills.
• Minimum 3‑5 years managing design projects and/or teams.
• Medical, healthcare, medical devices and/or pharmaceuticals background.
• Must be punctual, reliable, flexible, and excellent at balancing multiple detail‑oriented projects.
• High‑level attention to detail and accuracy in reducing errors in work deliverables.

• Create and update IFUs, reference guides, and carton artwork 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.
• 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).
• Support extension of department platform designs into individual projects. Communicate daily with other designers on impact to platform designs, and update platforms as appropriate.
• Maintain change history of instruction materials during their development.
• Produce low…