Software Test Engineer

Work Schedule: Monday – Friday (with flexibility to meet operational needs), on-site or hybrid (minimum 2d per week onsite) Boulder, Colorado

 

What You Will Do: 

• 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.

What You Will Bring:

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.

 Preferred Qualifications:

• 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 roo