Senior Human Factors Engineer (Medical Devices)

Location: Northfield, Illinois, United States

Salary: $101,000–$152,000 annual; bonus and/or incentive eligible.

Company

hirify.global is a growing worldwide medical device organization offering total rewards, professional development, and employee benefits.

What you will do

• Lead human factors and usability engineering activities from early concept through development, validation, and post-market surveillance.
• Plan and conduct formative and summative usability studies with end users, including protocols, surveys, use scenarios, moderator scripts, and reports.
• Conduct contextual inquiries, heuristic analyses, task analyses, and other user research to define user needs and identify use-related risks.
• Create usability engineering documentation, use specifications, usability plans, summary reports, risk analyses, and risk control measures.
• Lead Design Validation planning, simulated use studies, execution, and completion of validation deliverables.
• Improve procedures and templates, lead usability training workshops, and mentor engineers.

Requirements

• Bachelor’s degree in Human Factors Engineering, Usability Engineering, Cognitive or Experimental Psychology, Biomedical Engineering, Industrial Engineering, Cognitive Engineering, or a related field.
• At least 4 years of Human Factors Engineering experience.
• Experience with usability studies, user research, usability plans, summary reports, use-related risk assessments, and Design Validation.
• Knowledge of FDA guidance, AAMI HE 75, ISO 62366, IEC 60601-1-6, ISO 11607-1, 21 CFR 820.30 Design Controls, and ISO 14971 Risk Management.
• Willingness to travel up to 25% domestically and internationally.

Nice to have

• 7+ years of Human Factors Engineering experience in the medical device industry.
• Experience evaluating aseptic presentation requirements under Section 7 of ISO 11607-1.

Culture & Benefits

• Competitive total rewards package with continuing education and training.
• Health insurance, life and disability insurance, 401(k) contributions, and paid time off for eligible employees.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp access.
• Inclusive workplace focused on belonging, career growth, and providing employees with tools and resources to perform at their best.