Senior Human Factors Lead: Medical Device Usability

Medline Industries, LP; United States; On-site; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Employee Assistance Program

Job summary

Medline Industries, LP is seeking a Human Factors Engineer to lead HF activities across the product lifecycle, focusing on safe, effective medical device interfaces, packaging, labeling, and instructions for use. The role includes advising on design validation, conducting simulated use studies, and mentoring engineers to improve usability and reduce use errors.

The position requires a Bachelor's degree in a related field and a minimum of 4 years of HF Engineering experience.

Qualifications

• Bachelor's degree in a related field as listed.
• Minimum 4 years of Human Factor Engineering experience.
• Experience with formative and summative usability studies, including protocol and report generation.
• Strong knowledge of FDA guidance, AAMI HE 75, ISO 62366, IEC 60601-1-6, ISO 11607-1.
• Experience ensuring compliance with 21 CFR 820.30 Design Controls and ISO 14971 Risk Management.

Responsibilities

• Lead Human Factors activities across the product lifecycle, from concept to post-market surveillance.
• Develop usability strategies and provide guidance to product development teams.
• Lead and execute usability studies with end users across all stages of development.
• Create and maintain usability engineering documentation (plans, summaries, risk analyses).
• Mentor engineers on best practices and lead process improvement initiatives.

Skills

Human Factors Engineering

Usability Engineering

Risk Assessments

User Research

Cross-functional Collaboration

Mentoring

Education

Bachelor’s degree in Human Factors Engineering, Usability Engineering, Cognitive/Experimental Psychology, Biomedical Engineering, Industrial Engineering

Job description

Medline Industries, LP is seeking a Human Factors Engineer to lead HF activities across the product lifecycle, focusing on safe, effective medical device interfaces, packaging, labeling, and instructions for use. The role includes advising on design validation, conducting simulated use studies, and mentoring engineers to improve usability and reduce use errors.

The position requires a Bachelor's degree in a related field and a minimum of 4 years of HF Engineering experience.