Software Test Engineer

Foresight Diagnostics is a molecular diagnostics company pioneering non-invasive cancer detection through highly sensitive, cell-free DNA-based liquid biopsy technologies. Our proprietary methods - originally developed at Stanford University - are designed to detect smaller tumors earlier and enable more personalized treatment strategies for patients with cancer. We sit at the intersection of molecular biology, bioinformatics, and next-generation sequencing (NGS), and we translate rigorous science into clinically meaningful solutions. Following our acquisition by Natera, we now combine the agility of a mission-driven startup with the scale and resources of a global leader in cell-free DNA testing. Headquartered in Boulder, Colorado, our team operates in a high accountability, collaborative environment where quality and continuous improvement aren’t just values - they’re how we work every day.

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

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 have

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.

Benefits

Annual performance incentive bonus; Long-term equity awards; Comprehensive health benefits (medical, dental, vision); 401(k) with company match; Generous paid time off and company holidays; Additional wellness and work-life benefits; Life and disability plans for eligible employees and their dependents; Free testing for Natera employees and their immediate families; Fertility care benefits; Pregnancy and baby bonding leave; Commuter benefits; Employee referral program