Base Salary
$112k - $125k/yr
Responsibilities
- Design, develop, and execute manual and automated test cases for laboratory software systems.
- Validate software functionality, data integrity, and end-to-end workflow performance in a CLIA-regulated environment.
- Partner with laboratory operations to translate workflows into test scenarios and validation strategies.
- Identify, document, track, troubleshoot, and help resolve software defects with engineering teams.
- Support verification and validation for software releases, upgrades, and process changes under CLIA, CAP, NYSDOH, and internal quality standards.
- Maintain traceability between requirements, test cases, and validation documentation.
- Participate in risk assessments and impact analyses for software changes affecting laboratory operations.
- Improve software testing strategies, SOPs, and documentation practices.
- Maintain compliant testing documentation and support audits and inspections.
- Provide testing and laboratory workflow input to system requirements, user stories, change management, and operational improvement efforts.
Requirements
- Bachelor’s degree in a scientific discipline such as Biology, Molecular Biology, or Bioinformatics, or equivalent experience.
- At least 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, including CLIA, CAP, or equivalent standards.
- Experience writing and executing test cases from requirements and specifications.
- Strong attention to detail, including the ability to identify edge cases and failure modes.
- Excellent documentation skills focused on clarity, completeness, and compliance.
- Ability to translate complex operational workflows into structured test scenarios and validation strategies.
- Preferred experience testing LIMS, LIS, or other laboratory software systems.
- Preferred knowledge of the software development lifecycle and validation frameworks such as CSV and GxP.
- Preferred experience in high-complexity molecular diagnostics or MRD testing environments.
- Preferred familiarity with data validation, FASTQ, BAM, VCF, and bioinformatics pipelines.
- Preferred exposure to test automation tools or scripting, including Python or SQL.
- Preferred experience collaborating with engineering, bioinformatics, and quality teams.
- Preferred exposure to regulated change control processes and software impact assessments.
Benefits
- Annual performance incentive bonus, long-term equity awards, comprehensive medical, dental, and vision benefits, 401(k) with company match, paid time off, company holidays, and wellness and work-life benefits.
- Additional benefits include life and disability plans, free testing for employees and immediate families, fertility care benefits, pregnancy and baby bonding leave, commuter benefits, and an employee referral program.
- Monday–Friday schedule with flexibility to meet operational needs; Boulder, Colorado work arrangement is on-site or hybrid with a minimum of two days per week on-site.
About Natera
Natera™ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 325 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. Please be advised that Natera will only reach out to candidates with an @natera.com email domain. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes. https://www.natera.com/privacy/