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

DELFI Diagnostics, Inc. • Palo Alto, CA

8d • $85 - $92

About The Position

In this role, you will drive efforts to verify and validate the performance of an automated IVD Next-Generation Sequencing-based assay under development for early cancer detection. You will have the opportunity to design, plan and execute design verification studies that will serve as the basis for the assay’s analytical performance claims. Additionally, you will collaborate closely with the quality and regulatory functions to ensure that product design, development, and transfer comply with design control and risk management requirements.

Requirements

• Degree in relevant field (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
• High level of analytical ability to solve complex technical problems
• Proven ability to collaborate cross-functionally
• Skill in technical and non-technical communication

Nice To Haves

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

Responsibilities

• Help establish Delfi’s culture of compliance through scalable tools, structures, and processes for compliant product development
• Drive the verification and validation of products that are compliant with CLIA, FDA, and international regulatory standards
• Implement and improve Delfi’s design control process throughout all stages of the product life cycle
• Design, plan, and coordinate the execution of analytical validation (AV),other design verification studies or design transfer activities
• Collaborate with R&D and Lab Operations, Biostatisticians and Quality, Regulatory teams to create and execute study plans
• Prepare design verification and validation study documentation, such as study protocols and reportsContribute directly to FDA PMA submissions
• Create and present Formal Design Review presentations at key milestones
• Collaborate with Systems Engineering to document product requirements while ensuring the requirements are met during design verification

What This Job Offers

• Career Level: Senior
• Education Level: No Education Listed