Vacancy expired!
Position Title: SW Test Lead (IVD)
Location: South San Francisco, CA – must be onsite. Locals preferred, but client is open to NATIONALS THAT WILL RELOCATE to Bay Area to live here and work onsite.
LOA: 6 months contract to hire – salary range is $125-135K once converted to Perm.
Process: Resume submittal to first round phone screen with hiring manager for 45 minutes. Second round will involve 5 or 6 team members, 30 minutes each, via Zoom or MSFT Teams.
Background Check Required
Scope: As part of the fast-growing team in Genetic Testing Solutions, candidate will ensure the integrity, accuracy, and design compliance of software testing in an FDA regulated environment. Candidate will be involved with quality and test advocacy, test resource planning and management, and resolution of issues that impede the testing effort. Coordination of software testing activities will ensure software is fit for intended use, mitigates all identified risks, and is free of unexpected anomalies.
Job Duties:
• Define the scope of testing within the context of each software release
• Plan, deploy and manage the testing activities for any given engagement
• Estimate the testing effort and collaborate with management to acquire the necessary resources.
• Author, review, and approve verification protocols, reports, and trace matrices, ensuring design compliance, test coverage, and suitability of protocols for clinical laboratory software
• Determine the appropriate test measurements and metrics for the product
• Drive improvement in test methodologies and technologies for test automation, reporting, traceability, and defect management
• Ensure software verification and validation activities are in accordance with FDA guidance on testing and validation, design compliance with internal procedures, and to ensure suitability to intended use of the clinical product
• Ensure test toolsets are properly maintained, validated, and documented according to FDA guidance on Validation, and that the test environment is in place prior to test execution
• Participate in Software Hazard Analysis activities to ensure a full understanding of patient and safety risks for our clinical software products, and ensure that risk control measures are implemented correctly and tested accordingly
• Collaborate with algorithm engineers to develop algorithm test plans and unit testing protocols.
Education
B.S. in Molecular Biology, Biology, Microbiology, Biochemistry, or related technical discipline
Experience
• 5+ years of experience testing desktop or web-based applications in a clinical or diagnostic laboratory setting and in a FDA regulated environment
• 2+ years of experience leading software test teams to ensure the highest quality standard of product
• Experience with laboratory workflows in a clinical diagnostic environment
• Experience in new product development from product realization to product launch
• Prior experience in Agile software development methodology
• Utilized HP ALM, Jira, DOORS Next Generation
• Hands on experience with test automation tools
Knowledge, Skills, Abilities
• Ability to clearly communicate overall health of the product and status updates to key stakeholders
• Project planning and manage multiple work streams concurrently
• Deep understanding of qPCR and IVD genetic testing workflows in a clinical laboratory
