Senior Software V&V Engineer

Senior individual contributor role setting the V&V strategy across device software at Foresight Diagnostics, a wholly-owned subsidiary of Natera. The software portfolio spans bioinformatics pipelines, reagent QC systems, liquid handling automation, LIMS/LIS integrations, and NGS analysis tools, each subject to IEC 62304 and ISO 13485. The role serves as the quality and engineering bridge between bioinformatics, software, and lab teams and requires genuine bioinformatics or computational biology experience. Location flexibility with regular required travel to the Boulder, Colorado laboratory.

Responsibilities

Own verification and validation activities across the software portfolio; 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, including end-to-end workflows and individual NGS algorithms; 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 to resolve and document findings; Approve test reports and ensure documentation compliance under design controls; Establish and maintain V&V traceability, including oversight of software traceability matrices; 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

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 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; Excellent written and verbal communication skills, with the ability to translate complex technical findings into clear, compliant documentation

Nice to have

Testing experience with pipeline orchestration tools such as Nextflow; Hands-on exposure to clinical laboratory workflows, including CAP/CLIA environment experience; 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

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; Life and disability plans; Free testing and fertility care benefits for employees and immediate families; Pregnancy and baby bonding leave; Commuter benefits; Employee referral program