Human Factors Engineer

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: creating content, layout, and line-art illustrations; developing both low (simple sketch) and high-fidelity digital samples of instructional materials intended for print; supporting usability studies with quick design turn-arounds during iterative studies; balancing design thinking with regulatory requirements while developing instructional materials; and working closely with other members (FTE and EW) in the instruction design group (6-8 people).

Top 3 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 (ex., hands holding devices), and image editing. Proficient in Adobe Creative Suite (Illustrator, Photoshop, InDesign)

• Medical, healthcare, medical devices and/or pharmaceuticals background

• Must be punctual, reliable, flexible, and excellent at balancing multiple detail-oriented projects

Day to Day Responsibilities:

• Creates and updates IFU 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

• Collaborates with internal partners to develop production-level instructional materials to support product use

• Produces low (quick sketch) to high (refined digital files) fidelity prototypes of IFUs for design review during evolution

• Uses hand prototyping and assembly methods (printing, trimming, folding, binding, construction) to build models of IFUs, cartons, and other leaflets for use in HFE usability studies. Organizes and packs materials for shipping to usability studies

• Quickly transitions design explorations of multiple concepts/solutions to refining single design solutions

• Provides expertise and guidance in the content generation, illustrations, layout, and formatting of early stage IFUs

• Works under the supervision of Sr Instruction Designers in department

• Coordinates with cross-functional teams (including Human Factors, Device Engineering, Marketing Labeling, Clinical, Legal and Regulatory Affairs) to define instruction requirements

• Troubleshoots relatively complex problems

Red Flags for Recruiters:

• Only academic experience

• Past experience exclusively in marketing, branding, logos, websites without any experience designing instructions for regulated products

• Text-based instructions only (ex., SOP development without illustrations and layout, personnel training manuals)

Interview Process: To be considered, candidates must supply a design portfolio for review

Basic Qualifications:

Master’s degree

OR

Bachelor’s degree and 2 years of experience