Sr/Staff Software Test Engineer (Medical Devices)

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 officesWe are seeking an experienced Software Tester to support verification and validation of DELFIbuilt software as well as commercial off-the-shelf software. This role is an exciting opportunity for someone who thrives on cross-functional collaboration in a fast-paced, mission-driven environment where your technical expertise directly impacts patient outcomes. In this role, you will directly contribute to requirements review, software component/item testing, and integration testing to support release of software. This position works as part of a cross-functional team to define test strategy, methodology, automation, and to lead verification and validation activities.*Candidates must be located in the US**Strong preference for West Coast candidates*What you’ll doVerification and Validation: Develop and execute tests for verification and validation with a focus on risk, deliverables, and timelines.Leadership: Exemplify and champion test engineering best practices through automated and manual testing. Identifying and escalating coverage gaps in coverage.Test Automation: Develop and utilize test automation frameworks to build continuous testing solutions.Collaboration: Work with Data Science, Assay, Lab Operations, and other teams on verification and validation software release activities.Risk Management: Participate in risk management activities, including hazard analyses, FMEAs, and implementation of risk control measures.Quality and Compliance: Ensure product and system development aligns with GxP (including 21 CFR Part 11), HIPAA, IEC 62304 and 21 CFR 820 standards. Remain abreast of evolving regulatory guidelines on the use of AI in medical devices, and implement such guidelines in practice.Process Improvement: Document current processes, system configurations, identify challenges, and establish efficient and fit-for-purpose workflows for the test and software development lifecycle.Documentation and Regulatory Support: Develop and document work under design control and quality management systems, policies, and procedures. Create, review, and manage 21 CFR 820-compliant technical documents to support regulatory submissions.What you’ll have accomplished 12 months from nowLed testing for a software component and built comprehensive boundary tests.Automated software testing for medical devices and supporting systems.Built robust automated tests and contributed to continuous testing efforts.Played a critical role in the establishing safe and effective laboratory software and systems.What you’ll bring to DELFIRequired5+ years of experience in software testing in diagnostics or medical devices. 3+ years of test automation experience, preferably with custom frameworks.3+ years of experience writing test software, preferably in Python.Bachelor's degree in a relevant field (Bioinformatics, Computational Biology, Computer Science, or related discipline). Master's or advanced degree preferred.Experience with verification and validation strategies in Agile, adaptable to regulated environments.Experience setting up automated software testing infrastructure.Experience with data driven, API, or UI software testing and test automation frameworks (e.g. Cypress, Playwright, Selenium, Pytest).Experience with testing for US-IVD regulatory submissions (e.g. 510(k), de novo, PMA).Basic understanding of next-generation sequencing and bioinformatics concepts.Demonstrated ability to review software requirements.Exceptional cross-functional communication and proactive problem-solving skills with a demonstrated ability to build positive stakeholder relationships.Focus on continuous improvement of processes for software delivery.PreferredExperience in software testing or similar role in medical device software development.Experience in integrated testing and process validation.Experience with Playwright or similar tools.What we offer full-time employees100% paid medical, dental and vision premiums for employees and dependents4 months paid parental leaveFlexible Time Off5 day winter break in DecemberA meaningful mission and strong company cultureWe 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.Originally posted on Himalayas

Apply Now