Senior Software V&V Engineer
Core
Senior V&V Engineer owning verification and validation strategy for bioinformatics pipelines, NGS analysis tools, and lab automation software under IEC 62304 and ISO 13485.
Role type
Senior individual contributor V&V engineer (bioinformatics/NGS)
Builds
Bioinformatics pipelines, reagent QC systems, liquid handling automation, LIMS/LIS integrations, and NGS analysis tools
Domain
Molecular diagnostics, bioinformatics, next-generation sequencing (NGS)
Deliverable
production ML models
Required skills
Software verification and validation for regulated medical devices, NGS bioinformatics pipeline testing, cloud environment testing (AWS/GCP), ISO 13485 and IEC 62304 design controls, cross-functional collaboration with bioinformaticians and lab teams, bioinformatics or computational biology domain expertise
Preferred skills
Pipeline orchestration tools (Nextflow), clinical laboratory workflow experience (CAP/CLIA), LIMS/LIS platform familiarity, FDA submission preparation experience
Technologies
AWS, GCP, Nextflow, NGS analysis workflows
Responsibilities
Align software testing processes with IEC 62304 and ISO 13485 design control requirements, oversee V&V activities for pipeline software and lab automation, design and execute verification tests for NGS bioinformatics pipelines, develop and maintain IEC 62304-aligned test cases and protocols, review test cases and resolve variances with QA, approve test reports for documentation compliance, establish and maintain V&V traceability across device software and instruments, manage cadence and prioritization of V&V activities, travel to Boulder lab for testing and integration support