ABOUT US

Our mission is to cure cancer through high performance, accessible early cancer detection. That means saving lives.
Delfi Diagnostics is a Johns Hopkins spinoff focused on the non-invasive detection of cancer at earlier stages, when it is most curable. DELFI uses artificial intelligence and whole genome sequencing to detect unique patterns of DNA fragmentation in the blood of patients with cancer. These analyses are performed through simultaneous examination of millions of DNA sequences using machine learning to identify tumor-specific abnormalities.
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.

ABOUT THE ROLE

We are seeking an experienced Systems Engineer to facilitate the development of DELFI’s Bioinformatics Pipeline.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 prioritizing features, designing, developing, validating, documenting, and launching releases for our NGS-based diagnostics bioinformatics software. This position works as part of a cross-functional team to define user needs, translate product requirements, create specifications, identify and mitigate risks, lead verification and validation activities, and contribute to FDA submissions.

WHAT YOU’LL DO:

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• Requirements Management: Translate user needs and customer requirements into product and systems requirements and specifications, ensuring optimal implementation into product design.

• Stakeholder Collaboration: Collaborate with stakeholders in Data Science, Assay, Lab Operations, and other departments to gather and prioritize software requirements and drive software release activities.
• Strategic Roadmap Management: Maintain software and systems roadmaps that balance maintenance and routine upgrades, new features, system architecture considerations, and regulatory requirements.
• Risk Management: Participate in risk management activities, including hazard analyses, FMEAs, and implementation of risk control measures.
• Verification and Validation: Partner with the Software Quality and Testing teams to help design and execute verification and validation activities.
• Quality and Compliance: Ensure product and system development aligns with GxP (including 21 CFR Part 11), HIPAA compliance requirements, and where applicable, 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.
• Documentation and Regulatory Support: Develop and document work under design control and quality management systems, policies, and procedures. Support regulatory submission activities through creation, review, and management of 21 CFR 820-compliant technical documents.
• Process Improvement: Document current processes, system configurations, challenges, and opportunities while establishing efficient and fit-for-purpose workflows for the software and system development lifecycle.
• Leadership: Exemplify and champion design control and systems engineering values and techniques.