Senior Human Factors Engineer

Summary:
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.
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.

Top 5 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.

Basic Qualifications:

• Doctorate degree OR Master’s degree and 3 years of experience OR Bachelor’s degree and 5 years of experience OR Associate’s degree and 10 years of OR High school diploma / GED and 12 years of experience

Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on a number of factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.