Senior Software V&V Engineer

Role Description

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.

What You’ll Do

• Own verification and validation activities across Foresight's software portfolio.
• Work closely with bioinformaticians, software engineers, and clinical laboratory teams to ensure thorough testing and complete documentation.
• Align all software testing processes with IEC 62304 and ISO 13485 design control requirements.
• 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.
• Develop and maintain test templates, test protocols, and IEC 62304-aligned test cases.
• Review executed test cases, assess variances, and collaborate with the Quality Assurance team.
• 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.
• Manage the cadence, prioritization, and execution of V&V activities across concurrent programs.
• Travel to the Foresight lab in Boulder, CO regularly to support testing activities and cross-functional collaboration.

Qualifications

• 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.
• 2+ years of testing experience in cloud environments (AWS or GCP).
• Direct working knowledge of ISO 13485 and IEC 62304 design controls.
• 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.
• Excellent written and verbal communication skills.

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.

Benefits

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

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.