Job Title: 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) Posting Date: 05/09/2025 Pay Rate: Open Notes: 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 inperson in Thousand Oaks CA. Exceptional candidate with successful experience working remotely may be considered. Due to the prototype build responsibilities this role is inperson only in Thousand Oaks CA. There is no relocation for this position.
3 Key Consulting is hiring a Senior Human Factors Engineer for a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description: 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 inperson in Thousand Oaks CA. Exceptional candidate with successful experience working remotely may be considered. If candidate is within commuting distance to Thousand Oaks they will be expected to work onsite 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 lineart illustrations. Develops both low (simple sketch) and highfidelity 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 turnaround during iterative studies in a designtestrefinetest 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.
Handbuilds 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 crossfunctional partners to improve and document labeling across upstream and downstream functions.
Why is the Position Open Supplement additional workload on team/ backfill
Top Must Have Skills:
Minimum 510 years of instruction design experience including IFUs including strong proficiency in rapid sketch illustration digital lineart 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 35 yrs prototyping small volume (10100 pieces) cartons leaflets and labels for use in usability studies. Requires manual assembly and crafttype skills.
Minimum 35 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 detailoriented projects.
Highlevel attention to detail and accuracy in reducing errors in work deliverables.
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 crossfunctional 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 (quick sketch) to high (refined resolution) fidelity prototypes of IFUs reference guides and carton artwork for usability studies. High fidelity prototypes may require plotting trimming folding binding laminating and constructing cartons.
Provide expertise and guidance to Human Factors engineering partners and other crossfunctional partners with content generation illustrations layout and formatting of instruction materials.
Support process improvement programs and documentation of crossfunctional processes.
Troubleshoot relatively complex problems and issues.
Employee Value Proposition:
Career growth
Networking
Unique industry experience
Red Flags:
Only academic experience
Past experience exclusively in marketing branding logos websites without any experience writing instructions for regulated products
Only juniorlevel experience designing; we need seniorlevel experience and thinking for this role. Requires experience managing design projects and working with multiple stakeholders
Textbased instructions only (ex. SOP development without illustrations and layout personnel training manuals defense user manuals)
No prototyping experience.
Interview process: To be considered candidates MUST supply an online portfolio
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