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

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 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. 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 in-person 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 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.

Why is the Position Open?
Supplement additional workload on team/ backfill

Top Must Have Skills:

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 yrs 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.

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).
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 cross-functional partners with content generation, illustrations, layout, and formatting of instruction materials.
Support process improvement programs and documentation of cross-functional processes.
Manage junior staff and/or oversee external vendors to execute design work.
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 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)
No prototyping experience.

Interview process:
To be considered, candidates MUST supply an online portfolio

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.