Senior Staff Scientist, IVD Assay Verification and Validation (Contract)

DELFI Diagnostics, Inc. is developing next-generation, blood-based tests for early cancer detection. The company prioritizes solutions that can save lives on a global scale. This role will drive efforts to verify and validate the performance of an automated IVD Next-Generation Sequencing-based assay.

Requirements

• Degree in biomedical engineering, molecular biology, genetics, or genomics
• Minimum of 10 years of experience developing IVD products in regulated environments
• Expertise in IVD regulatory requirements (FDA 21 CFR Part 820, ISO14971, ISO13485, IVDR)
• Demonstrated IVD and AV experience gained from development and ideally FDA approval of multi-marker genomic or other ’omic assays

Benefits

• Generous Paid Time Off
• 401k Matching
• Tuition Reimbursement