Software Test Engineer

Responsibilities

• Design, develop, and execute test cases based on software requirements, functional specifications, and user needs for laboratory systems
• Perform manual and/or automated testing to validate software functionality, data integrity, and workflow performance in a CLIA-regulated environment
• Partner closely with laboratory operations teams to understand end-to-end workflows and translate them into effective test scenarios
• Identify, document, and track software defects; collaborate with engineering teams to troubleshoot and resolve issues
• Support validation and verification activities for new software releases, system upgrades, and process changes in accordance with CLIA, CAP, NYSDOH, and internal quality standards
• Ensure traceability between requirements, test cases, and validation documentation
• Participate in risk assessments and impact analyses related to software changes affecting laboratory operations
• Contribute to the development and continuous improvement of software testing strategies, SOPs, and documentation practices
• Support audits and inspections by maintaining clear, thorough, and compliant testing documentation
• Act as a quality advocate, ensuring software supports accurate, reliable, and timely patient testing results
• Partner with Operational Excellence to align test strategies with process design, workflow optimization, and scalability initiatives.
• Provide input into system requirements and user stories based on laboratory workflow expertise and testing insights.
• Support critical feedback loops to ensure continuous improvements to software systems.
• Support change management efforts by assessing downstream operational impact of software releases and enhancements.

Requirements

• Minimum Requirements:
• Bachelor's degree in a scientific discipline (e.g., Biology, Molecular Biology, Bioinformatics) or related field, or equivalent experience
• 2+ years of experience in software testing, quality assurance, or validation, preferably in a regulated environment
• Familiarity with NGS workflows and/or clinical laboratory operations (CLIA, CAP, or equivalent)
• Experience writing and executing test cases based on requirements and specifications
• Strong attention to detail and ability to identify edge cases and failure modes
• Excellent documentation skills with a focus on clarity, completeness, and compliance
• Demonstrated ability to translate complex operational workflows into structured test scenarios and validation strategies.
• Experience testing LIMS, LIS, or other laboratory software systems
• Knowledge of software development lifecycle (SDLC) and validation frameworks (e.g., CSV, GxP)
• Experience working in high-complexity molecular diagnostics or MRD testing environments
• Familiarity with data validation, NGS file formats (e.g., FASTQ, BAM, VCF), and/or bioinformatics pipelines
• Exposure to test automation tools or scripting (e.g., Python, SQL)
• Experience working cross-functionally with engineering, bioinformatics, and quality teams
• Exposure to regulated change control processes and software impact assessments in regulated environments.
• Key Competencies
• Quality Mindset: Operates with a strong understanding of regulated environments and the importance of compliance, accuracy, and reproducibility
• Attention to Detail: Able to rigorously evaluate software behavior and identify subtle defects or inconsistencies
• Problem Solving: Approaches issues methodically, with a focus on root cause analysis and practical solutions
• Systems Thinking: Understands how software, workflows, and laboratory operations interconnect and impact one another across the full testing lifecycle.
• Operational Acumen: Demonstrates awareness of real-world laboratory constraints, throughput considerations, and process dependencies.
• Collaboration : Works effectively across technical and non-technical teams to drive outcomes
• Adaptability: Thrives in a fast-paced, evolving environment with shifting priorities
• OUR OPPORTUNITY

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