Software Test Engineer

Natera • Boulder, CO, CO

8h • Hybrid

About The Position

Natera™ is seeking a Software Test Engineer to join our team. This role involves designing, developing, and executing test cases for laboratory systems, performing manual and automated testing, and collaborating with laboratory operations and engineering teams. The ideal candidate will ensure software quality and compliance within a CLIA-regulated environment, supporting validation activities, risk assessments, and continuous improvement of testing strategies. This position plays a crucial role in ensuring software supports accurate, reliable, and timely patient testing results and aligns with operational excellence initiatives.

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.

Nice To Haves

• 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.

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.

Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• Free testing for employees and their immediate families
• Fertility care benefits
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits
• Generous employee referral program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level