💼 About This Role

You'll support the verification and validation of an automated IVD NGS-based assay for early cancer detection, contributing to design and documentation of analytical validation studies. This role directly impacts FDA submission packages and product design control.

🎯 What You'll Do

• Design and execute analytical validation studies for IVD assays.
• Prepare study protocols, reports, and design verification documentation.
• Collaborate with R&D, Quality, and Regulatory on study plans and compliance.
• Contribute to FDA PMA submission packages and design reviews.

📋 Requirements

• Doctoral degree in Molecular Biology or related field with 4+ years of relevant experience.
• 2+ years developing IVD products in regulated environments.
• Working knowledge of IVD regulatory requirements (FDA 21 CFR Part 820, ISO14971, ISO13485, IVDR).
• Hands-on analytical validation experience with genomic or multi-marker assays.

✨ Nice to Have

• Experience with design transfer or manufacturing of IVD products.
• Exposure to or direct participation in PMA submissions.

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Phone Screen· 30 min
2. 2Technical Interview· 60 min
3. 3Onsite Interview· Full day