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Sr. Software Quality Assurance Engineer I

Tandem · California - High Bluff · On-site

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About Tandem

AI-native office leasing broker. Backed by Y Combinator and a16z.

About the role

Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We’d love for you to team up with us to “innovate every day,” put “people first,” and take the “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry. This role will be a mix of in-office work at our corporate headquarters in Del Mar, CA and remote work.

What they're looking for

  • Bachelor's degree in Engineering, Computer Science, Software Engineering, Biomedical Engineering, or a related technical discipline
  • Minimum 5 years of experience in software quality assurance, software quality engineering, or related quality functions within the medical device or other regulated industry
  • Experience supporting software development from concept through commercial release
  • Experience with Design Controls, risk management, software verification and validation, and software anomaly management
  • Knowledge of medical device software development processes, including mobile, embedded, and web-based technologies
  • Working knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971, IEC 62304, and other applicable medical device regulations and standards
More about this role

Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We’d love for you to team up with us to “innovate every day,” put “people first,” and take the “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry.

Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology — an advanced predictive algorithm that automates insulin delivery. But we’re so much more than that. Our company’s human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.com

Serves as the Software Quality Assurance Engineer supporting software product development programs, ensuring software products are developed, validated, and maintained in compliance with applicable quality system and regulatory requirements. Applies knowledge of...

Read the full posting on Tandem's site ↗

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