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Senior Software V&V Engineer (Bioinformatics)
Описание вакансии
Текст:
TL;DR
Senior Software V&V Engineer (Bioinformatics): Designing and executing verification and validation strategies for regulated medical device software and NGS bioinformatics pipelines with an accent on regulatory compliance (IEC 62304/ISO 13485) and cloud-based testing. Focus on ensuring the highest standards of clinical diagnostics, managing traceability matrices, and bridging the gap between bioinformaticians and lab teams.
Location: US Remote with regular required travel to Boulder, Colorado
Company
is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health.
What you will do
- Lead V&V activities across the software portfolio, including bioinformatics pipelines, lab automation, and LIMS/LIS tools.
- Align all software testing processes with IEC 62304 and ISO 13485 design control requirements.
- Design and execute verification tests for NGS bioinformatics pipelines, analysis workflows, and individual algorithms.
- Develop and maintain audit-ready test templates, protocols, and IEC 62304-aligned test cases.
- Establish and maintain comprehensive V&V traceability matrices across all device software components and lab instruments.
- Collaborate cross-functionally with bioinformaticians, software engineers, and clinical laboratory teams.
Requirements
- Must be based in the US
- 4+ years of experience conducting software V&V for regulated medical device software (510(k) and/or PMA pathways).
- 3+ years of experience designing and executing verification tests specifically for NGS bioinformatics pipelines.
- 2+ years of testing experience in cloud environments (AWS or GCP).
- Direct applied working knowledge of ISO 13485 and IEC 62304 design controls.
- Direct work experience in bioinformatics, computational biology, or a biology-related field is a hard requirement.
Nice to have
- Testing experience with pipeline orchestration tools such as Nextflow.
- Hands-on exposure to clinical laboratory workflows (CAP/CLIA environment).
- Familiarity with LIMS/LIS platforms in a regulated diagnostic context.
- Experience preparing V&V documentation for FDA submissions.
Culture & Benefits
- Comprehensive medical, dental, vision, life, and disability plans.
- Free genetic testing and fertility care benefits for employees and their immediate families.
- 401k and commuter benefits.
- Pregnancy and baby bonding leave.
- High-accountability, collaborative environment focused on quality and continuous improvement.