--- title: 'IVD Documentation Scientist, Manufacturing and Medical Device (Contract) at DELFI Diagnostics, Inc.' canonical: 'https://feeny.ai/job/ivd-documentation-scientist-manufacturing-and-medical-device-contract-delfi-zzcfhgh4mdm8' type: 'job' last_seen: '2026-09-12' --- # IVD Documentation Scientist, Manufacturing and Medical Device (Contract) at DELFI Diagnostics, Inc. - **Company:** DELFI Diagnostics, Inc. - **Location:** Palo Alto, CA - **Compensation:** $62–$80/hr - **Employment:** contract - **Work type:** hybrid - **Posted:** 2026-08-10 - **Last confirmed live:** 2026-09-12 - **Apply:** https://jobs.lever.co/delfidiagnostics/63594c54-276f-4071-a3b1-7f827996b626 ## Job description ## About Us DELFI 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 offices We are seeking an experienced scientist who is a subject-matter expert in GMP reagent manufacturing under ISO 13485 and IVD medical device documentation. This role will be the key individual responsible for the manufacturing documentation required for a high risk IVD device meeting the rigor of FDA’s PMA and IVDR’s Class C/D submission including Specifications and Procedures for Manufacturing, Packaging, Storage, Handling, Distribution and Process Controls.  The focus will be working closely with the assay development, reagent manufacturing, regulatory, and quality teams to craft the procedures, templates, and documentation that govern high-quality reagent manufacturing execution, including batch records, CoAs, study plans, reports, SOPs, and design history file content. ## What you’ll do IVD documentation (Manufacturing and Medical Device) - Author and revise existing reagent manufacturing and qualification procedures to ensure processes are repeatable and meet GMP and IVD quality documentation expectations including 21 CFR 820 and ISO 13485 requirements - Author batch record templates and finalize batch manufacturing records (BMRs) for GMP reagent manufacturing processes, including incoming receipt, in-process, and release steps - Develop Certificates of Analysis (CoAs) and specification documents for GMP-grade reagents, controls, and raw materials, aligned with regulatory expectations - Write and maintain manufacturing study plans and summary reports for lot qualification, lot-to-lot variability, stability, and process characterization studies - Draft and revise SOPs, work instructions, and manufacturing process descriptions for inclusion in the Device History Record (DHR) and Device Master Record (DMR) - Develop and maintain Design History File (DHF) documentation packages to support PMA submission, including manufacturing development reports, risk assessments, and design transfer documentation, process validation, equipment and software qualification - Compile and organize manufacturing evidence packages (batch records, qualification data, CoAs, validation reports) for regulatory submission - Support other IVD documentation as needed, such as FMEA, BOMs, trace matrix CMO & Supplier Coordination - Review CMO-generated documentation (batch records, CoAs, deviation reports) for GMP compliance prior to lot release - Support incoming QC workflows and receiving-to-release documentation for in-house and CMO-manufactured reagents GMP Manufacturing Experience - Prior hands-on experience in the preparation of GMP-grade reagents, controls, and reference standards (formulation, aliquoting, labeling, packaging) following SOPs and batch records - Ability to complete hands-on training and bench execution of step-by-step manual reagent preparation, observe and identify potential failure modes, recommend improvements, and update existing documentation to meet GMP/FDA/IVD expectations - Work with reagent manufacturing operators to ensure QC testing and real-time batch records are completed during manufacturing runs ## What you'll bring to DELFI Required - BS+7, MS+5, or PhD+3 years in GMP manufacturing or tech transfer within IVD, medical device, or pharma - Hands-on experience with manual GMP manufacturing: reagent formulation, controlled preparation, aliquoting, labeling, and release QC testing - Prior experience operating lab equipment in GMP-controlled environments with strict contamination control and cleanroom protocols - Demonstrated expertise authoring GMP documentation: BMRs, CoAs, study plans, manufacturing reports, SOPs, and process validation packages - Direct experience in eQMS document control, including creating, revising, and approving quality documents. - Direct experience contributing to FDA PMA, 510(k), or BLA/NDA submission packages — specifically manufacturing sections - Strong working knowledge of 21 CFR Part 820, ISO 13485, and design control requirements - Experience with CMO oversight including review of CMO-generated documentation ## Preferred - Background in NGS-based assays, molecular diagnostics, or immunoassay platforms - Hands-on experience with protein- or nucleic acid-based reagent manufacturing, including recombinant protein controls or reference standards - Familiarity with DHF/DMR structure, CLSI guidelines, ISO 14971 risk documentation, and ERP/lot-tracking systems (e.g., NetSuite) We 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. ## About DELFI Diagnostics, Inc. ## Company Overview - **One-liner**: DELFI Diagnostics is a precision oncology company that uses AI and whole-genome sequencing to analyze DNA fragmentation patterns in blood for early cancer detection. - **Entity Type**: Private (Late-Stage) - **Headquarters**: Palo Alto, California, USA - **Founded**: 2019 - **Founders**: Victor Velculescu, MD, PhD (and colleagues at Johns Hopkins University) ## Core Business - Primary industry: Precision Oncology / Liquid Biopsy / Healthcare Diagnostics - Target customers: B2B (Health systems, primary care providers, pulmonologists, lung screening programs) and B2B for research (Pharmaceutical companies) - Mission: "Make cancer less deadly through widely accessible early detection" ## Products & Services - **[FirstLook™ Lung](https://delfidiagnostics.com/)**: A blood-based, AI-powered laboratory-developed test (LDT) for lung cancer screening. Designed for adults eligible under USPSTF guidelines, it uses whole-genome sequencing and machine learning to analyze cell-free DNA fragmentation patterns. It boasts a 99.8% Negative Predictive Value and is intended to be a noninvasive first step before low-dose CT (LDCT) scans. Became commercially available in October 2023. - **[DELFI-TF Treatment Monitoring](https://delfidiagnostics.com/)**: A research service for pharmaceutical companies conducting Phase 1-2 clinical trials. It provides non-invasive, real-time treatment response assessment using cell-free DNA fragmentomes, offering short turnaround times and a low-cost solution. ## Market Standing - **Valuation**: Not publicly disclosed - **Key Metric**: Total Funding of **over $325 million** - **Notable Investors/Partners**: DFJ Growth, Eli Lilly and Company, Merck Global Health Innovation Fund (equity investment announced June 2024), OrbiMed, Point72, T. Rowe Price. - **Growth Signals**: - The FirstLook Lung test is commercially available, marking a major milestone from R&D to clinical deployment. - Completed three major clinical trials (L101 validation study, CASCADE-LUNG/L201 prospective cohort study, L301/FIRSTLUNG randomized controlled trial). - Has a strong intellectual property foundation, with its core technology first published in *Nature* in 2019. - Strategic equity investment from Merck (2024) signals pharma validation and potential for partnership. ## Competitive Advantages - **Proprietary Fragmentomics Platform**: Their AI-driven computational platform analyzes genome-wide patterns of cell-free DNA fragmentation, capturing signals that conventional mutation-based liquid biopsies often miss. This provides a broader, more sensitive view of cancer biology. - **Strong Clinical Validation**: The technology is backed by peer-reviewed publications in top journals (*Nature*, *Cancer Discovery*) and multiple registered clinical trials (NCT04825834, NCT05306288, NCT06145750). - **High Clinical Utility**: The test's 99.8% Negative Predictive Value provides high confidence to rule out lung cancer, which is a powerful tool for clinicians managing screening decisions. - **Focus on Accessibility**: Designed for large-scale health system deployment with EHR integration, provider support, and a low-cost structure to make screening widely available. ## Strategic Focus - **Market Expansion**: Driving commercial adoption of FirstLook Lung within health systems, primary care, and lung screening programs across the US. - **Clinical Evidence Generation**: Continuing to generate robust clinical data through trials like CASCADE-LUNG to further validate the technology's performance and clinical utility. - **Pharma Partnerships**: Expanding the DELFI-TF treatment monitoring service to partner with more pharmaceutical companies for drug development. - **Product Pipeline**: Likely developing additional screening tests for other cancer types using the same fragmentomics platform. ## Why Work Here - **High-Impact Mission**: The company is singularly focused on "making cancer less deadly," offering employees a direct role in a potentially transformative technology. - **Culture & Values**: DELFI emphasizes three core values guiding all interactions and decisions. They actively seek to build a diverse, inclusive, and healthy workplace so employees can do their best work. - **Hybrid/Remote Flexibility**: DELFI supports hybrid and remote work options for most positions, with labs and offices in Palo Alto, CA, and Baltimore, MD. Employees receive a one-time $400 home office subsidy. - **Comprehensive Compensation**: Offers a competitive base salary, target bonus plan, and an equity program so everyone has a stake and feels ownership. - **Generous Benefits**: - Non-accrual time off (flexible PTO) and a 5-day winter break. - DELFI pays 100% of the medical premium for employee and family. - 16 weeks of paid parental leave. - 401(k) and annual merit cycle. - **Learning & Growth**: Wide-ranging learning and development programs to help employees continue to develop their skills. - **Team & Leadership**: A dynamic, passionate group of executive leaders, clinical and data scientists, engineers, and commercial team members, led by experienced experts from relevant fields. ## Sources 1. [delfidiagnostics.com](https://delfidiagnostics.com/) 2. [delfidiagnostics.com/about-us/](https://delfidiagnostics.com/about-us/) 3. [delfidiagnostics.com/about-us/careers/](https://delfidiagnostics.com/about-us/careers/) 4. [jobs.lever.co/delfidiagnostics](https://jobs.lever.co/delfidiagnostics) 5. [delfidiagnostics.com/about-us/leadership-team/](https://delfidiagnostics.com/about-us/leadership-team/) ## Other roles at DELFI Diagnostics, Inc. - [Manager Equipment Service Engineering](https://feeny.ai/job/manager-equipment-service-engineering-delfi-diagnostics-inc-palo-alto-ev10x2yvgs6c) — Palo Alto, CA - [Accounting Operations Manager](https://feeny.ai/job/accounting-operations-manager-delfi-diagnostics-inc-palo-alto-2q3fjaratz5w) — Palo Alto, CA - [Sr. Data Scientist, Assay Development](https://feeny.ai/job/sr-data-scientist-assay-development-delfi-diagnostics-inc-palo-alto-e021867zf5tq) — Palo Alto, CA - [Director / Senior Director, Market Access & Reimbursement](https://feeny.ai/job/director-senior-director-market-access-reimbursement-delfi-diagnostics-inc-n4z44ygzc0e5) - [Senior Clinical Laboratory Associate / Equipment Engineer (Contract)](https://feeny.ai/job/senior-clinical-laboratory-associate-equipment-engineer-contract-delfi-59t1g1rbhy4a) — Palo Alto, CA - [Automation Engineer I/II (Contract)](https://feeny.ai/job/automation-engineer-i-ii-contract-delfi-diagnostics-inc-palo-alto-zfxef259gcph) — Palo Alto, CA - [Senior Director, Clinical Development](https://feeny.ai/job/senior-director-clinical-development-delfi-diagnostics-inc-palo-alto-06vxbzpnzjqq) — Palo Alto, CA - [Senior Staff, Software Engineer](https://feeny.ai/job/senior-staff-software-engineer-delfi-diagnostics-inc-remote-bjpcbxmnjyd2)