Senior Software V&V Engineer

The role

You will own verification and validation activities across the software portfolio. This includes setting V&V strategy, managing testing cadence, and serving as a bridge between bioinformatics, software, and lab teams.

What you will do

• Align software testing processes with IEC 62304 and ISO 13485 design control requirements
• Oversee V&V activities for pipeline software, lab automation, reagent QC software, and LIMS/LIS tools
• Design and execute software verification tests for NGS bioinformatics pipelines
• Develop and maintain test templates, protocols, and IEC 62304-aligned test cases
• Review executed test cases and collaborate with Quality Assurance to resolve findings
• Approve test reports and ensure documentation compliance under design controls
• Establish and maintain V&V traceability across device software and lab instruments
• Manage the cadence, prioritization, and execution of V&V activities
• Travel to the Foresight lab in Boulder, CO on a regular basis

Required qualifications

• 4+ years conducting and overseeing software V&V for regulated medical device software (510(k) and/or PMA pathways)
• 3+ years designing and executing verification tests for NGS bioinformatics pipelines
• 2+ years of testing experience in cloud environments (AWS or GCP)
• Direct working knowledge of ISO 13485 and IEC 62304 design controls
• 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

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 contributing to or preparing for FDA submissions (510(k) or PMA)

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

About the company

Foresight Diagnostics is a molecular diagnostics company and a wholly-owned subsidiary of Natera. The company pioneers non-invasive cancer detection through cell-free DNA-based liquid biopsy technologies.