Foresight Diagnostics Inc.

Engineer

• Own verification and validation activities across Foresight's software portfolio — working closely with bioinformaticians, software engineers, and clinical laboratory teams to ensure every system is tested thoroughly and documented completely.
• Align all software testing processes with IEC 62304 and ISO 13485 design control requirements, and ensuring the team operates consistently within that framework.
• Oversee V&V activities for pipeline software, lab automation methods, reagent QC software, LIMS/LIS tools, and select laboratory instruments.
• Design and execute software verification tests for NGS bioinformatics pipelines — including tests for end-to-end analysis workflows and individual NGS algorithms.
• Develop and maintain test templates, test protocols, and IEC 62304-aligned test cases that are clear, complete, and audit-ready.
• Review executed test cases, assess variances, and collaborate with the Quality Assurance team to resolve and document findings appropriately.
• Approve test reports and ensure full documentation compliance under design controls.
• Establish and maintain V&V traceability across device software, lab automation tools, and lab instruments — including oversight of software traceability matrices across all device software components.
• Manage the cadence, prioritization, and execution of V&V activities across concurrent programs.
• Traveling to the Foresight lab in Boulder, CO on a regular basis to support testing activities, lab integration work, and cross-functional collaboration.

Senior Software V&V Engineer