💼 About This Role

You'll drive the human factors strategy for AI-driven medical device software, ensuring compliance with IEC 62366-1 and FDA guidance. Your work will directly impact the usability of products used in over 500,000 patients worldwide. This role offers the chance to shape clinical workflows for a publicly traded health tech leader.

🎯 What You'll Do

• Establish SaMD human factors and usability strategies per regulations.
• Execute and document usability engineering evaluations and studies.
• Author formative and summative usability study protocols.
• Perform root cause analysis of use errors and report findings.

📋 Requirements

• BS/MS in Human Factors or related discipline.
• 7+ years human factors engineering in medical devices or SaMD.
• Deep knowledge of IEC 62366-1 and FDA Human Factors guidance.
• Proven ownership of summative studies supporting regulatory submissions.

✨ Nice to Have

• Experience with cardiovascular imaging or AI/ML clinical decision support.
• Simulated-use studies in high-fidelity clinical environments.
• CHFP or CPE certification.

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Hiring Manager Interview· 60 min
3. 3Technical Interview· 60 min