Job Title: Human Factors Engineer Onsite (JP14073) 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.
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 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 lineart 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 designtestrefinetest 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 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 46 years of experience reviewing documents including medical device IFUs. including strong proficiency in rapid sketch illustration digital lineart illustration and image (photo) editing.
24 years experience using Adobe Creative Suite software (InDesign and Illustrator) and Microsoft Word and Excel. Knowledge of Microsoft Access and Visio is a plus.
Highlevel attention to detail and accuracy in reducing errors in work deliverables.
Medical healthcare medical devices and/or pharmaceuticals background.
Must be punctual reliable flexible and excellent at balancing multiple detailoriented projects. Strong organization and communication skills.
Day to Day 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. Some reviews will use digital comparison tools; other reviews will require manual checking.
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 crossfunctional 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.
Employee Value Proposition:
Career growth
Networking
Unique industry experience
Red Flags:
Review experience with textbased instructions only (ex. SOP development without illustrations and layout personnel training manuals defense user manuals). This role needs applicants with experience reviewing graphics as well as copy.
Only has checking experience; role requires ability to contribute to improving processes involving design and checks.
Interview process:
To be considered candidates MUST supply an online portfolio
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