Senior Software V&V Engineer

📋 Description

• Aligning all software testing processes with IEC 62304 and ISO 13485 design control requirements
• Overseeing V&V activities for pipeline software, lab automation methods, reagent QC software
• Designing and executing software verification tests for NGS bioinformatics pipelines—including
• Developing and maintaining test templates, test protocols, and IEC 62304-aligned test cases that
• Reviewing executed test cases, assessing variances, and collaborating with the Quality Assurance
• Approving test reports and ensuring full documentation compliance under design controls.

🎯 Requirements

• 4+ years conducting and overseeing software verification and validation activities for regulated
• 3+ years designing and executing verification tests specifically for NGS bioinformatics
• 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
• Prior experience working cross-functionally with bioinformaticians, software engineers, and
• Prior work experience in bioinformatics, computational biology, or a biology-related field—this is

🎁 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