Senior Software V&V Engineer

📋 Description

• Own V&V across Foresight's software with bioinformaticians and lab teams.
• Align testing with IEC 62304 and ISO 13485 design controls.
• Oversee V&V for pipelines, lab automation, LIMS/LIS, and instruments.
• Design and execute tests for NGS bioinformatics pipelines and algorithms.
• Develop IEC 62304-aligned test templates and protocols.
• Establish V&V traceability and cadences across programs; travel to Boulder.

🎯 Requirements

• 4+ years conducting and overseeing V&V for regulated medical device software.
• 3+ years designing/executing verification tests for NGS bioinformatics pipelines.
• 2+ years testing in cloud environments (AWS or GCP).
• Direct working knowledge of ISO 13485 and IEC 62304 design controls.
• Cross-functional experience with bioinformaticians, software engineers, and labs.
• Preferred: Nextflow, CAP/CLIA exposure, LIMS/LIS familiarity, FDA submissions.

🎁 Benefits

• Comprehensive medical, dental, vision, life, and disability benefits.
• Free testing for employees and immediate families, plus fertility care benefits.
• Pregnancy and baby bonding leave.
• 401k retirement benefits.
• Commuter benefits.
• Generous employee referral program.