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

About UsDELFI Diagnostics, Inc. (DELFI Diagnostics) is developing next-generation, blood-based tests that are reliable, accessible and deliver a new way to help detect cancer. Employing advanced machine-learning methods to whole-genome sequencing data, the DELFI ("DNA EvaLuation of Fragments for early Interception") platform is built to address the highest-burden health challenges. DELFI Diagnostics prioritizes solutions that have the potential to save lives on a global scale, including for historically underserved populations. DELFI Diagnostics’ platform relies on fragmentomics – the discovery that cancer cells are more chaotic than normal cells and, when they die, leave behind tell-tale patterns and characteristics of cell-free DNA (cfDNA) fragments. FirstLook Lung, for individuals eligible for lung cancer screening, is DELFI Diagnostics’ first laboratory-developed screening test and can be part of routine blood work. FirstLook Lung uses millions of data points to reliably identify individuals who may have cancer detected through low-dose CT, including early stage disease with a negative predictive value of 99.8 percent. This test has not been cleared or approved by the FDA.In our passionate pursuit to radically improve health outcomes, we serve humanity when we:Lead with Science, Anchor in Pragmatism: We pioneer life-changing science by ensuring quality, transparency, and rigor at all times. We explore thoughtfully, experiment smartly, and deliver impact with conviction. Build With & For All: We embrace diverse backgrounds to innovate and achieve together. We are not just building a product - we aim to disrupt the path of cancer for all - no matter geography or socioeconomic class Put We over I: We are a home for high-performing people. Through teamwork, we build collective intelligence. Each of us wins when those we serve and those who serve with us--win. We show up with empathy, humility, and integrity at every step of the journey.DELFI has 1-2 designated in-office working days each week for employees who live within within 50 miles of Palo Alto CA or Baltimore MD officesAbout the RoleIn 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.What you’ll doHelp establish Delfi’s culture of compliance through scalable tools, structures, and processes for compliant product developmentDrive the verification and validation of products that are compliant with CLIA, FDA, and international regulatory standardsImplement and improve Delfi’s design control process throughout all stages of the product life cycleDesign, plan, and coordinate the execution of analytical validation (AV),other design verification studies or design transfer activitiesCollaborate with R&D and Lab Operations, Biostatisticians and Quality, Regulatory teams to create and execute study plansPrepare design verification and validation study documentation, such as study protocols and reportsContribute directly to FDA PMA submissionsCreate and present Formal Design Review presentations at key milestonesCollaborate with Systems Engineering to document product requirements while ensuring the requirements are met during design verificationWhat you'll bring to DELFI (Required) Degree in relevant field (biomedical engineering, molecular biology, genetics, or genomics)Minimum of 10 years of experience developing IVD products in regulated environmentsExpertise 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 assaysHigh level of analytical ability to solve complex technical problemsProven ability to collaborate cross-functionallySkill in technical and non-technical communicationWhat you'll bring to DELFI (Preferred) MS or PhD in relevant fieldExperience with design transfer and/or manufacturing of IVD productsDirect experience with PMA submissionsWe are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.This position is not eligible for agency partnership. Resumes and outreach from staffing representatives will be declined.