Senior Human Factors Engineer
$101,000–$152,000 year
On-siteNorthfield, Illinois, United States
Job Summary
Lead Human Factors and usability engineering activities across the product lifecycle for Class I and II medical devices, guiding product design from early concept through post-market surveillance. Develop and execute usability strategies, including formative and summative studies, to minimize use errors while collaborating with cross-functional teams on device interfaces, packaging, and labeling. Author protocols, surveys, and reports; conduct contextual inquiries and heuristic analyses to distill insights that optimize design and mitigate risks. Plan and complete Design Validation activities, including simulated use studies, and create risk control measures aligned with FDA and ISO standards. Mentor engineers and lead process improvement initiatives to ensure compliance with industry regulations.
Required Qualifications
- Bachelor's degree in Human Factors Engineering, Usability Engineering, Cognitive/Experimental Psychology, Biomedical Engineering, Industrial Engineering, Cognitive Engineering, or related field
- Minimum 4 years of Human Factor Engineering experience
Desired Qualifications
- 7+ years of Human Factors Engineering experience in the medical device industry preferred
- Extensive experience conducting formative and summative usability studies, including protocol and report generation
- Experience conducting user research activities, such as task/workflow analysis, interviews, focus groups, surveys, and voice of customer activities, including contextual inquiry
- Proficient in creating usability plans, summary reports, and use-related risk assessments
- Experience with Design Validation, including planning, conducting simulated use studies, and documenting results
- Strong knowledge of industry standards regarding human factors and usability (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
- Experience conducting evaluations to meet aseptic presentation requirements per Section 7 of ISO 11607-1
- Willing to travel up to 25% of the time for business purposes (domestic and international)
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