💼 About This Role

You'll drive verification and validation of an automated IVD NGS-based assay for early cancer detection, ensuring compliance with CLIA, FDA, and ISO standards. You'll design and execute analytical validation studies supporting regulatory submissions.

🎯 What You'll Do

• Design and execute analytical validation studies for IVD assays
• Prepare study protocols and reports for FDA submissions
• Collaborate with cross-functional teams on design control
• Present Design Review presentations at key milestones

📋 Requirements

• Degree in biomedical engineering, molecular biology, genetics, or genomics
• 10+ years developing IVD products in regulated environments
• Expertise in FDA 21 CFR Part 820, ISO14971, ISO13485, IVDR
• Proven IVD/AV experience with multi-marker genomic assays

✨ Nice to Have

• MS or PhD in relevant field
• Experience with design transfer or manufacturing of IVD products
• Direct experience with PMA submissions