Senior Software Quality Engineer - Medical Devices

August 29

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Tempus Labs, Inc.

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Tempus is advancing data-driven precision medicine with the practical application of AI in healthcare. It’s About Time.

1001 - 5000

Description

• Serve as Software Quality lead for Tempus’ SDLC projects/activities that include laboratory developed tests, investigational device software, and commercialization of medical devices (SiMD and SaMD). • Provide FDA/ISO Design Controls mentoring to various cross-functional teams, including R&D, lab operations, software engineering, bioinformatics, and IT teams. • Ensure applicable quality required documentation, such as DHF deliverables, are generated and maintained throughout SDLC of software products, including SRS, SAD, SDS, V&V, traceability, risk management/FMEA and cyber-security. • Apply innovative, scalable, and risk-based approaches to meeting compliance for novel technologies in a fast-paced, multi-project environment. • Maintain knowledge of the evolving regulatory landscape for Digital Health, Artificial Intelligence and Machine Learning technologies, and incorporate best practices in Tempus’ SDLC processes and QMS. • Support compliance to various QMS procedures and activities including, but not limited to risk management, internal and external audits, change control, and training. • Support and own software QMS procedures. • Performs other related duties and responsibilities as assigned.

Requirements

• BA/B.S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines. • 5+ years in a software quality (design assurance/controls) role in the medical device/IVD (or FDA regulated) industry. • Experience and working knowledge of applicable regulations and standards: FDA QSR, ISO 13485, IEC 62304, ISO 14971 • Expertise in SDLC best practices, and experience with state-of-the-art SDLC tools such as Atlassian (Jira) and Jama. • Experience with Agile/Scrum/iterative software development methodology. • Ability to deliver quality outputs under minimal supervision.