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Job Title: Senior Human Factors Engineer, Instructions Design Lead – Can be Remote (JP12091) Location: Thousand Oaks, CA. 91320 (Can be remote) Business Unit: Human Factors & Usability Groupe Employment Type: Contract Duration: 1+ years (with possible extensions) Rate : Market Rate Posting Date: 12/15/2023 Notes: Only qualified candidates need apply. 3 Key Consulting is recruiting an Human Factors Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description: 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. Maintains history records to capture rationale for changes over the development of the instructions. Top Must Have Skill Sets: 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 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. If remote, must have experience working remotely from others in team.

Day to Day Responsibilities: 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) to define instructional requirements and execute on plans.

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 (quick sketch) to high (refined digital files) fidelity prototypes of IFUs, reference guides, and carton artwork for usability studies. High fidelity prototypes may require plotting, trimming, folding, binding, laminating, and constructing structural cartons. Provide expertise and guidance to Human Factors engineering partners and other cross-functional partners with content generation, illustrations, layout, and formatting of instruction materials.

Manage junior staff and/or oversee external vendors to execute design work. Troubleshoot relatively complex problems and issues. Basic Qualifications: Doctorate degree OR Master's degree and 3 years of experience OR Bachelor's degree and 5 years of experience OR Associate's degree and 10 years of OR High school diploma / GED and 12 years of experience Why is the Position Open?

Supplement additional workload on team Red Flags: Only academic experience Past experience exclusively in marketing, branding, logos, websites without any experience writing instructions for regulated products Only junior-level experience designing; we need senior-level experience and thinking for this role. Requires experience managing design projects and working with multiple stakeholders Text-based instructions only (ex., SOP development without illustrations and layout, personnel training manuals, defense user manuals) Interview Process: TBD We invite qualified candidates to sendyour resume to resumes@3keyconsulting.com . Ifyou decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our websitewww.3keyconsulting.com/careers.

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