Senior Software V&V Engineer

About the role

Ensure the quality and compliance of critical software used in cancer diagnostics. This role focuses on verifying and validating bioinformatics pipelines and related systems to meet stringent regulatory standards. You will be a key contributor to the accuracy and reliability of our diagnostic results.

Key facts

What you'll do

• Oversee verification and validation processes for software components, including bioinformatics pipelines, lab automation, and quality control systems.
• Develop and execute comprehensive test plans, protocols, and cases aligned with IEC 62304 and ISO 13485.
• Ensure complete traceability of software requirements through testing activities.
• Review test results, analyze deviations, and collaborate with teams to resolve issues.
• Approve test reports and maintain documentation for regulatory compliance.
• Manage the scheduling and prioritization of V&V tasks for multiple projects.

Requirements

• Minimum 4 years of experience in software verification and validation for regulated medical devices.
• At least 3 years of experience testing NGS bioinformatics pipelines, including workflows and algorithms.
• 2+ years of experience testing in cloud environments such as AWS or GCP.
• Demonstrated practical knowledge of ISO 13485 and IEC 62304 design controls.
• Proven ability to collaborate effectively with bioinformaticians, software engineers, and laboratory personnel.
• Essential background in bioinformatics, computational biology, or a related biological science.
• Strong written and verbal communication skills for clear technical documentation.

Nice to have

• Experience with pipeline orchestration tools like Nextflow.
• Familiarity with clinical laboratory operations in a CAP/CLIA setting.
• Exposure to LIMS/LIS platforms within a diagnostic context.
• Experience supporting FDA submissions (510(k) or PMA) from a V&V documentation perspective.

Skills & tools

• Software Verification & Validation
• IEC 62304
• ISO 13485
• NGS Bioinformatics Pipelines
• Cloud Environments (AWS, GCP)
• Test Plan Development
• Test Protocol Creation
• Traceability Matrix Management

Practical notes

• This role requires periodic travel to our laboratory in Boulder, Colorado. Travel frequency will be discussed during the interview process and will depend on project needs.
• Natera offers comprehensive benefits, including medical, dental, vision, life, and disability plans, as well as fertility care benefits and 401k.
• Natera will only contact candidates from @natera.com email domains. Be aware of potential employment scams.