Senior Software V&V Engineer

Natera

4d • Hybrid

About The Position

When a clinician receives an MRD result from our platform, every line of software that touches that result needs to have been verified and validated to the highest standard. At Foresight Diagnostics — now part of Natera — that responsibility belongs to our V&V team. We're looking for a Senior Software V&V Engineer who understands bioinformatics pipelines deeply enough to test them rigorously, and who brings the regulatory fluency to ensure every test case, protocol, and traceability matrix holds up under scrutiny.

ABOUT FORESIGHT DIAGNOSTICS
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.

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.

Nice To Haves

• 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

• 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.
• Align all software testing processes with IEC 62304 and ISO 13485 design control requirements, and ensuring the team operates consistently within that framework.
• Oversee V&V activities for pipeline software, lab automation methods, reagent QC software, LIMS/LIS tools, and select laboratory instruments.
• Design and execute software verification tests for NGS bioinformatics pipelines — including tests for end-to-end analysis workflows and individual NGS algorithms.
• Develop and maintain test templates, test protocols, and IEC 62304-aligned test cases that are clear, complete, and audit-ready.
• Review executed test cases, assess variances, and collaborate with the Quality Assurance team to resolve and document findings appropriately.
• Approve test reports and ensure full documentation compliance under design controls.
• Establish and maintain V&V traceability across device software, lab automation tools, and lab instruments — including oversight of software traceability matrices across all device software components.
• Manage the cadence, prioritization, and execution of V&V activities across concurrent programs.
• Travel to the Foresight lab in Boulder, CO on a regular basis to support testing activities, lab integration work, and cross-functional collaboration.

Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
• Free testing for employees and their immediate families.
• Fertility care benefits.
• Pregnancy and baby bonding leave.
• 401k benefits.
• Commuter benefits.
• Generous employee referral program.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed