Senior Human Factors Engineer, Instructions For Use/Medical Device - Remote

Senior Human Factors Engineer

3 Key Consulting is hiring! We are recruiting a Senior Human Factors Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:

To be considered, candidates MUST supply an online portfolio.

This is expected to be a contract position within our client's Human Factors and Usability Engineering group, working 40 hours/week. The position is for 1 year and may be renewed at the end of that period. This position can be remote or in-person at the client's Thousand Oaks, CA headquarters. If the candidate is within commuting distance of Thousand Oaks, they will be expected to work on-site most/all hours. There is no relocation for this position.

• 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.
• 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.

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.
• 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) 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.
• 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.

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)

Why is the Position Open?

Interview Process:

Video conference

We invite qualified candidates to send your resume to View email address on click.appcast.io. 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 You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.