Staff Scientist, IVD Validation & Design Control

Delfidiagnostics; Palo Alto (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

DELFI Diagnostics in Palo Alto, CA, is seeking a highly experienced professional to join the verification and validation of an automated NGS-based assay for early cancer detection. Reporting to the Principal Scientist of AV, you will help design, execute, and document verification studies and ensure design control and risk management compliance.

You will collaborate with QA, Regulatory, R&D, Lab Operations, and Biostatistics to deliver robust analytical validation, design transfer, and FDA PMA

Qualifications

• Doctoral or master/bachelor with extensive IVD experience in regulated settings.
• Experience developing IVD products in regulated environments (FDA/ISO).
• Ability to design verification, validation, and design transfer studies.

Responsibilities

• Support verification and validation of automated IVD NGS-based assay under development.
• Collaborate with quality and regulatory to ensure design control and risk management compliance.
• Design, plan, and execute AV studies and design transfer activities.
• Prepare study protocols and reports for validation and transfer.
• Contribute to FDA PMA submission packages under guidance.
• Present data at formal design reviews and program milestones.
• Collaborate with R&D, Lab Operations, Biostatisticians, and QA teams to execute study plans.

Skills

Regulatory collaboration

Analytical problem solving

Cross-functional communication

Genomics familiarity

Education

Doctoral degree in Molecular Biology/related

Master’s degree +7 years IVD experience

Bachelor’s degree +9 years IVD experience

Job description

DELFI Diagnostics in Palo Alto, CA, is seeking a highly experienced professional to join the verification and validation of an automated NGS-based assay for early cancer detection. Reporting to the Principal Scientist of AV, you will help design, execute, and document verification studies and ensure design control and risk management compliance.

You will collaborate with QA, Regulatory, R&D, Lab Operations, and Biostatistics to deliver robust analytical validation, design transfer, and FDA PMA