In this role, you will support the verification and validation of an automated IVD Next-Generation Sequencing-based assay under development for early cancer detection. Reporting directly to the Principal Scientist leading the analytical validation (AV) program, you will contribute to the design, execution, and documentation of design verification studies that will serve as the basis for the assay’s analytical performance claims. You will collaborate closely with quality and regulatory functions to help ensure that product design, development, and transfer comply with design control and risk management requirements.
Support Delfi’s culture of compliance by contributing to scalable tools, structures, and processes for compliant product development.
Assist in the verification and validation of products compliant with CLIA, FDA, and international regulatory standards, under the direction of the Principal Scientist.
Contribute to the execution of Delfi’s design control process throughout all stages of the product life cycle.
Design, plan, and execute analytical validation (AV) studies, other design verification studies, and design transfer activities as assigned by the Principal Scientist.
Collaborate with R&D, Lab Operations, Biostatisticians, and Quality and Regulatory teams to execute study plans.
Prepare design verification and validation study documentation, including study protocols and reports.
Contribute to FDA PMA submission packages under the guidance of the Principal Scientist.
Prepare and present data at Formal Design Reviews and key program milestones.
Collaborate with Systems Engineering to document product requirements and support design verification activities that confirm requirements are met.
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Salary: $140000-190000
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