Delfi Diagnostics

Full-stack Engineer

• Set long-term technical strategy and architectural vision for our bioinformatics pipeline systems
• Lead system architecture and high-stakes design reviews end-to-end, guiding the team through the most complex technical tradeoffs
• Design and own data hand-off and integration architecture between software systems
• Serve as a leader in engineering best practices—establishing standards, driving software-development lifecycle (SDLC) rigor
• Drive requirements engineering, risk analysis, and verification strategies for regulated software components
• Architect and own the DevOps strategy for the pipeline team, including cybersecurity, CI/CD, infrastructure-as-code
• Mentor and develop staff and senior engineers, raising the team's technical ceiling

Senior Staff, Software Engineer

Director

• Own end-to-end assay development strategy across all LDT and IVD programs — from study design and execution through protocol approval, analytical validation, regulatory documentation, and FDA PMA submissions
• Establish and enforce compliant analytical performance claims aligned to CLIA, FDA, and international IVD standards (21 CFR Part 820, ISO 13485, ISO 14971, IVDR)
• Contribute to and/or lead Formal Design Reviews at key milestones; partner with Systems Engineering to ensure product requirements are fully addressed through design verification
• Oversee reagent development and qualification, automated process scale-up, and statistical process control (SPC) for lab production environments
• Lead design transfer activities across programs, ensuring robust handoffs to manufacturing and sustained assay performance at commercial scale
• Report directly to the CTO; lead a team of scientists and functional leaders across assay development, validation, and manufacturing readiness
• Design and own the operational infrastructure for the function — scalable processes, SOPs, design control frameworks, and traceability systems aligned to 21 CFR Part 820 and ISO 13485
• Apply hands-on scientific judgment to make deliberate risk decisions — knowing where to push for speed and where standards are non-negotiable — keeping programs moving against ambitious timelines without compromising quality or integrity
• Represent Assay Development at the executive level; align with the CTO, VP of Regulatory & Quality, and other senior leaders on portfolio priorities and product strategy

Senior Staff, Software Engineer

Senior Director, Assay Development