Senior Software V&V Engineer
New
F
Foresight DiagnosticsMolecular diagnostics
US RemoteFull-TimeSenior
Salary$108,700.00 - $140,000
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Job Details
- Experience
- 4+ years conducting and overseeing software verification and validation activities for regulated medical device software; 3+ years designing and executing verification tests specifically for NGS bioinformatics pipelines; 2+ years of testing experience in cloud environments (AWS or GCP).
- Required Skills
- AWSGCP
Requirements
- Have 4+ years conducting and overseeing software verification and validation for regulated medical device software, including 510(k) and/or PMA pathways.
- Have 3+ years designing and executing verification tests for NGS bioinformatics pipelines, including analysis workflows and individual algorithm testing.
- Have 2+ years of testing experience in cloud environments using AWS or GCP.
- Bring direct, applied knowledge of ISO 13485 and IEC 62304 design controls.
- Have prior work experience in bioinformatics, computational biology, or a biology-related field.
- Have experience working cross-functionally with bioinformaticians, software engineers, and clinical laboratory teams.
- Be comfortable with periodic in-person presence and travel to the Boulder, Colorado laboratory.
- Experience with pipeline orchestration tools such as Nextflow is preferred.
- Clinical laboratory workflow experience, including CAP/CLIA environments, is preferred.
- Familiarity with LIMS/LIS platforms in regulated diagnostics is preferred.
- Experience contributing to or preparing FDA submissions from a V&V documentation standpoint is preferred.
Responsibilities
- Align software testing processes with IEC 62304 and ISO 13485 design control requirements.
- Oversee V&V activities for pipeline software, lab automation methods, reagent QC software, LIMS/LIS tools, and select laboratory instruments.
- Design and execute verification tests for NGS bioinformatics pipelines, including end-to-end analysis workflows and individual algorithms.
- Develop and maintain test templates, test protocols, and IEC 62304-aligned test cases.
- Review executed test cases, assess variances, and collaborate with Quality Assurance to resolve and document findings.
- Approve test reports and ensure documentation compliance under design controls.
- Establish and maintain V&V traceability, including oversight of software traceability matrices across device software components.
- Manage the cadence, prioritization, and execution of V&V activities across concurrent programs.
- Travel to the Boulder laboratory to support testing, lab integration, and cross-functional collaboration.
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