Natera - Senior Software V&V Engineer
Requirements
• 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. • Preferred • 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.
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.
Benefits
• 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 AND TRAVEL • LOCATION AND 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. • This range reflects a good-faith estimate of the base pay we reasonably expect to offer at the time of hire. Final compensation will vary based on experience, qualifications, and internal equity considerations. • This position is also eligible for additional compensation and benefits through Natera’s robust Total Rewards program, including: • Annual performance incentive bonus • Long-term equity awards • Comprehensive health benefits (medical, dental, vision) • 401(k) with company match • Generous paid time off and company holidays • Additional wellness and work-life benefits • Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! • For more information, visit www.natera.com.
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