Csv Validation Engineer Jobs in Colorado (NOW HIRING)

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

Location: On-Site in Boulder, CO (Foresight Dx business unit, a Natera company)

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. It's an exciting moment to join us. 

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.

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 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

Compensation & Total Rewards 

This range reflects a good-faith estimate of the base pay we reasonably expect to offer at the time of hire. Final compensation will vary based on experience, qualifications, and internal equity considerations.

This position is also eligible for additional compensation and benefits through Natera's robust Total Rewards program, including:

• 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

Compensation Range

$111,600.00 - $125,000.00