Senior Software V&V Engineer

WHY THIS ROLE EXISTS

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.

WHAT YOU’LL DO

• 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.

WHAT YOU’LL BRING

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 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.

WHY JOIN US

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.