Senior Software V&V Engineer

Natera

3h•$108,700 - $140,000

About The Position

Foresight Diagnostics, a wholly owned subsidiary of Natera, is seeking a senior individual contributor to own verification and validation (V&V) across its regulated software portfolio. The portfolio includes bioinformatics pipelines, reagent quality-control systems, liquid-handling automation, LIMS/LIS integrations, NGS analysis tools, and select laboratory instruments. The role sets V&V strategy, manages testing cadence and priorities, and connects quality and engineering teams across bioinformatics, software, and clinical laboratory functions. Software activities must meet IEC 62304 and ISO 13485 requirements and the rigor expected in clinical diagnostics. The engineer will work with bioinformaticians, software engineers, and clinical laboratory teams to plan, execute, review, and document testing. Work includes verification tests for NGS pipelines and algorithms, maintaining audit-ready test materials and traceability, reviewing test results and variances, and approving test reports. Regular travel to the Foresight laboratory in Boulder, Colorado is required to support testing, lab integration, and collaboration. The position offers location flexibility, with work performed remotely or on-site in Boulder and periodic in-person presence at the lab.

Requirements

At least 4 years conducting and overseeing software V&V for regulated medical device software using 510(k) and/or PMA pathways.
At least 3 years designing and executing verification tests specifically for NGS bioinformatics pipelines, including NGS analysis workflows and individual algorithm testing.
At least 2 years of testing experience in AWS or GCP cloud environments.
Applied working knowledge of ISO 13485 and IEC 62304 design controls.
Prior cross-functional experience working 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.
Excellent written and verbal communication skills, including the ability to translate complex technical findings into clear, compliant documentation.
Comfort with periodic in-person presence and regular travel to the Boulder, Colorado laboratory.

Nice To Haves

Testing experience with pipeline orchestration tools such as Nextflow.
Hands-on exposure to clinical laboratory workflows; CAP/CLIA environment experience is an advantage.
Familiarity with LIMS/LIS platforms in a regulated diagnostic context.
Experience contributing to or preparing FDA submissions (510(k) or PMA) from a V&V documentation standpoint.

Responsibilities

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