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Senior Software Quality Engineer - Medical Devices

Tempus

Tempus

Quality Assurance
Chicago, IL, USA
Posted on Friday, May 24, 2024

Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

We are looking for a Senior Software Quality Engineer (Software Design Controls) who will be involved in the software quality management system (QMS) and software development life cycle (SDLC) activities, in accordance with FDA’s Quality System Regulation (QSR), ISO 13485, CAP/CLIA, and other applicable regulatory requirements, as well as best practices in the software industry. You will report to the Manager of Software Quality and will play a key role in producing quality software products.

Responsibilities:

  • 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.

Required Education & Experience:

  • 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.
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We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.