Senior Software V&V Engineer
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Job Description
Senior Software V&V Engineer ensuring thorough verification and validation of software in cancer diagnostics. Collaborate with cross-functional teams for bioinformatics pipeline testing and regulatory compliance.
Responsibilities:
- You'll 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.
- Aligning all software testing processes with IEC 62304 and ISO 13485 design control requirements, and ensuring the team operates consistently within that framework.
- Overseeing V&V activities for pipeline software, lab automation methods, reagent QC software, LIMS/LIS tools, and select laboratory instruments.
- Designing and executing software verification tests for NGS bioinformatics pipelines — including tests for end-to-end analysis workflows and individual NGS algorithms.
- Developing and maintaining test templates, test protocols, and IEC 62304-aligned test cases that are clear, complete, and audit-ready.
- Reviewing executed test cases, assessing variances, and collaborating with the Quality Assurance team to resolve and document findings appropriately.
- Approving test reports and ensuring full documentation compliance under design controls.
- Establishing and maintaining V&V traceability across device software, lab automation tools, and lab instruments — including oversight of software traceability matrices across all device software components.
- Managing 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.
Requirements:
- 4+ years conducting and overseeing software verification and validation activities for regulated medical device software (510(k) and/or PMA pathways).
- 3+ years designing and executing verification tests specifically for NGS bioinformatics pipelines — including NGS analysis workflows and individual algorithm testing.
- 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 familiarity.
- 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 — this is a hard requirement for this role.
- Excellent written and verbal communication skills, with the ability to translate complex technical findings into clear, compliant documentation.
Benefits:
- Medical, dental, and vision
- Flexible PTO and paid holidays
- Parental leave
- 401(k) with company match
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