Software Test Engineer
Core
Design, develop, and execute test cases for laboratory systems to validate software functionality, data integrity, and workflow performance in a CLIA-regulated environment.
Role type
Software Test Engineer (Regulated Life Sciences)
Builds
Laboratory software systems for cell-free DNA testing, oncology, and organ health diagnostics
Domain
Clinical Laboratory / Molecular Diagnostics / Regulated Software
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Test case design and execution, Manual and automated testing, Validation and verification (CSV/GxP), Defect tracking and root cause analysis, Regulatory compliance documentation (CLIA/CAP/NYSDOH), Workflow translation to test scenarios
Preferred skills
LIMS/LIS testing, SDLC knowledge, NGS workflows and file formats (FASTQ/BAM/VCF), Test automation scripting (Python/SQL), Cross-functional collaboration with bioinformatics and engineering
Technologies
LIMS, LIS, Python, SQL, NGS pipelines
Responsibilities
Design and execute test cases based on functional specifications, Perform manual and automated testing to validate software in CLIA environments, Partner with operations to translate workflows into test scenarios, Identify and document software defects, Support validation activities for new releases and upgrades, Ensure traceability between requirements and test documentation, Participate in risk assessments for software changes, Contribute to testing strategies and SOPs, Support audits and inspections, Act as a quality advocate for patient testing results, Align test strategies with process optimization initiatives, Provide input on system requirements and user stories, Support change management and impact assessments
Seniority
Mid-level, hands-on IC
