Natera - Senior Software V&V Engineer

• 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 testing. • 2+ years of testing experience in cloud environments (AWS or GCP). • Direct working knowledge of ISO 13485 and IEC 62304 design controls — applied experience, not just familiarity. • Prior experience working cross-functionally with bioinformaticians, software engineers, and clinical laboratory teams. • Prior work experience in bioinformatics, computational biology, or a biology-related field — this is a hard requirement for this role. • Excellent written and verbal communication skills, with the ability to translate complex technical findings into clear, compliant documentation. • Testing experience with pipeline orchestration tools such as Nextflow. • Hands-on exposure to clinical laboratory workflows — CAP/CLIA environment experience is a meaningful advantage. • Familiarity with LIMS/LIS platforms in a regulated diagnostic context. • Experience contributing to or preparing for FDA submissions (510(k) or PMA) from a V&V documentation standpoint. • This is a technically sophisticated role at the intersection of bioinformatics and regulated software quality — a combination that's genuinely rare and increasingly in demand as molecular diagnostics scales. You'll work on software systems that directly enable MRD detection for cancer patients, alongside scientists and engineers who take both the science and the standards seriously. • With Natera's backing and Foresight's mission, you'll have the resources of an established organization and the ownership opportunities of a focused, growing team. We invest in our people and promote from within for those who deliver. • LOCATION & TRAVEL • This role offers location flexibility with regular required travel to our Boulder, Colorado laboratory. Travel frequency will be discussed during the interview process and will vary based on program needs, audit schedules, and lab integration milestones. Candidates should be comfortable with periodic in-person presence as a genuine part of the role. • OUR OPPORTUNITY • OUR OPPORTUNITY • Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives. • The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.