Senior Software V&V Engineer

LOCATION: Remote or On-Site Boulder, CO ABOUT FORESIGHT DIAGNOSTICS (A wholly-owned subsidiary of Natera) Foresight Diagnostics is a molecular diagnostics company pioneering non-invasive cancer detection through highly sensitive, cell-free DNA-based liquid biopsy technologies. Our proprietary methods - originally developed at Stanford University - are designed to detect smaller tumors earlier and enable more personalized treatment strategies for patients with cancer. We sit at the intersection of molecular biology, bioinformatics, and next-generation sequencing (NGS), and we translate rigorous science into clinically meaningful solutions. Following our acquisition by Natera, we now combine the agility of a mission-driven startup with the scale and resources of a global leader in cell-free DNA testing. It’s an exciting moment to join us. Headquartered in Boulder, Colorado, our team operates in a high accountability, collaborative environment where quality and continuous improvement aren’t just values - they’re how we work every day. ABOUT THE ROLE Our software portfolio spans bioinformatics pipelines, reagent QC systems, liquid handling automation, LIMS/LIS integrations, and NGS analysis tools. Each component carries regulatory obligations under IEC 62304 and ISO 13485, and each needs to be verified and validated with the rigor that clinical diagnostics demands. This is a senior individual contributor role with real ownership — you'll set the V&V strategy across device software, manage the cadence and prioritization of testing activities, and serve as the quality and engineering bridge between bioinformatics, software, and lab teams. The candidate must bring genuine bioinformatics or computational biology experience: this isn't a role where you can learn the domain on the job. PRIMARY RESPONSIBILITIES You'll own verification and validation activities across Foresight's software portfolio — working closely with bioinformaticians, software engineers, and clinical laboratory teams to ensure every system is tested thoroughly and documented completely. In practice, that means: • • Aligning all software testing processes with IEC 62304 and ISO 13485 design control requirements, and ensuring the team operates consistently within that framework. • Overseeing V&V activities for pipeline software, lab automation methods, reagent QC software, LIMS/LIS tools, and select laboratory instruments. • Designing and executing software verification tests for NGS bioinformatics pipelines — including tests for end-to-end analysis workflows and individual NGS algorithms. • Developing and maintaining test templates, test protocols, and IEC 62304-aligned test cases that are clear, complete, and audit-ready. • Reviewing executed test cases, assessing variances, and collaborating with the Quality Assurance team to resolve and document findings appropriately. • Approving test reports and ensuring full documentation compliance under design controls. • Establishing and maintaining V&V traceability across device software, lab automation tools, and lab instruments — including oversight of software traceability matrices across all device software components. • Managing the cadence, prioritization, and execution of V&V activities across concurrent programs. • Traveling to the Foresight lab in Boulder, CO on a regular basis to support testing activities, lab integration work, and cross-functional collaboration. QUALIFICATIONS • Required • 4+ years conducting and overseeing software verification and validation activities for regulated medical device software (510(k) and/or PMA pathways). • 3+ years designing and executing verification tests specifically for NGS bioinformatics pipelines — including NGS analysis workflows and individual algorithm