Senior/Staff Software Test Engineer

Summary

Join DELFI Diagnostics, a company developing next-generation blood-based cancer detection tests, as a Software Tester. You will play a critical role in verifying and validating DELFI-built and commercial software, directly impacting patient outcomes. This position involves developing and executing tests, championing best practices in automated and manual testing, and collaborating with cross-functional teams. You will contribute to requirements review, software component/item testing, and integration testing to support software releases. The role also includes participation in risk management and ensuring compliance with relevant regulations. This is a full-time position with benefits.

Requirements

• 5+ years of experience in software testing in diagnostics or medical devices
• 3+ years of test automation experience, preferably with custom frameworks
• 3+ years of experience writing test software, preferably in Python
• Bachelor's degree in a relevant field (Bioinformatics, Computational Biology, Computer Science, or related discipline). Master's or advanced degree preferred
• Experience with verification and validation strategies in Agile, adaptable to regulated environments
• Experience setting up automated software testing infrastructure
• Experience with data driven, API, or UI software testing and test automation frameworks (e.g. Cypress, Playwright, Selenium, Pytest)
• Experience with testing for US-IVD regulatory submissions (e.g. 510(k), de novo, PMA)
• Basic understanding of next-generation sequencing and bioinformatics concepts
• Demonstrated ability to review software requirements
• Exceptional cross-functional communication and proactive problem-solving skills with a demonstrated ability to build positive stakeholder relationships
• Focus on continuous improvement of processes for software delivery

Responsibilities

• Verification and Validation: Develop and execute tests for verification and validation with a focus on risk, deliverables, and timelines
• Leadership: Exemplify and champion test engineering best practices through automated and manual testing. Identifying and escalating coverage gaps in coverage
• Test Automation: Develop and utilize test automation frameworks to build continuous testing solutions
• Collaboration: Work with Data Science, Assay, Lab Operations, and other teams on verification and validation software release activities
• Risk Management: Participate in risk management activities, including hazard analyses, FMEAs, and implementation of risk control measures
• Quality and Compliance: Ensure product and system development aligns with GxP (including 21 CFR Part 11), HIPAA, IEC 62304 and 21 CFR 820 standards. Remain abreast of evolving regulatory guidelines on the use of AI in medical devices, and implement such guidelines in practice
• Process Improvement: Document current processes, system configurations, identify challenges, and establish efficient and fit-for-purpose workflows for the test and software development lifecycle
• Documentation and Regulatory Support: Develop and document work under design control and quality management systems, policies, and procedures. Create, review, and manage 21 CFR 820-compliant technical documents to support regulatory submissions
• Led testing for a software component and built comprehensive boundary tests
• Automated software testing for medical devices and supporting systems
• Built robust automated tests and contributed to continuous testing efforts
• Played a critical role in the establishing safe and effective laboratory software and systems

Preferred Qualifications

• Experience in software testing or similar role in medical device software development
• Experience in integrated testing and process validation
• Experience with Playwright or similar tools

Benefits

• 100% paid medical, dental and vision premiums for employees and dependents
• 4 months paid parental leave
• Flexible Time Off
• 5 day winter break in December
• A meaningful mission and strong company culture