Senior Human Factors Design Engineer

ATR International; Minneapolis (MN); On-site; USD 110,000 - 140,000; Full time

Job summary

ATR International is seeking a Senior Human Factors Design Engineer to support the development and validation of a Class III medical device, focusing on clinician-facing components of a sacral neuromodulation system.

The role involves designing formative, pre-summative, and usability validation studies, owning protocols and URRAs, moderating sessions, and collaborating with cross-functional teams to ensure regulatory-ready documentation.

Qualifications

• Approximately 5–10 years of experience in human factors, usability engineering, or a related field.
• Experience designing and executing medical device human factors validation studies.
• Hands-on experience moderating usability research sessions.
• Experience authoring Use-Related Risk Analyses and maintaining risk traceability.
• Strong usability data analysis and technical report-writing skills.
• Experience working with cross-functional product development teams.
• Bachelor’s or advanced degree in Human Factors, Psychology, Biomedical Engineering, Industrial Design, or a related discipline.

Responsibilities

• Design and execute formative, pre-summative, and human factors validation studies.
• Own study protocols, including protocol writing and ensuring accurate risk traceability.
• Moderate formative and summative usability study sessions with intended users.
• Partner with research operations on participant recruitment and study logistics.
• Author and maintain Use-Related Risk Analyses (URRAs).
• Analyze qualitative and quantitative usability data and translate findings into actionable design recommendations.
• Collaborate with human factors, systems engineering, design, quality, and regulatory teams.
• Prepare clear study reports and supporting documentation for regulatory submissions.
• Help define user needs, usability requirements, and human-machine interface improvements.

Skills

Human factors

Usability engineering

Moderating sessions

Data analysis

Technical report writing

Education

Degree in Human Factors

Job description

We are seeking a Senior Human Factors Design Engineer to support the development and validation of a Class III medical device, with a focus on clinician-facing components of a sacral neuromodulation system.

Key Responsibilities

• Design and execute formative, pre-summative, and human factors validation studies.
• Own study protocols, including protocol writing and ensuring accurate risk traceability.
• Moderate formative and summative usability study sessions with intended users.
• Partner with research operations on participant recruitment and study logistics.
• Author and maintain Use-Related Risk Analyses (URRAs).
• Analyze qualitative and quantitative usability data and translate findings into actionable design recommendations.
• Collaborate with human factors, systems engineering, design, quality, and regulatory teams.
• Prepare clear study reports and supporting documentation for regulatory submissions.
• Help define user needs, usability requirements, and human-machine interface improvements.

Required Qualifications

• Approximately 5–10 years of experience in human factors, usability engineering, or a related field.
• Experience designing and executing medical device human factors validation studies.
• Hands-on experience moderating usability research sessions.
• Experience authoring Use-Related Risk Analyses and maintaining risk traceability.
• Strong usability data analysis and technical report-writing skills.
• Experience working with cross-functional product development teams.
• Bachelor’s or advanced degree in Human Factors, Psychology, Biomedical Engineering, Industrial Design, or a related discipline.

Preferred Qualifications

• Experience supporting Class III, implantable, or neuromodulation medical devices.
• Familiarity with clinician-facing interfaces and workflows.
• Knowledge of FDA human factors guidance and IEC 62366.