Job Description


Job Description:
Baxter is seeking a Sr. Principal Software Quality Engineer with + years of progressive experience in medical device Quality Engineering, supporting both hardware and software development. This role provides technical leadership for product quality, design control, risk management, and software quality assurance activities across new and existing product lines.

Responsibilities:

Primary Duties:
  • Provide Quality Engineering leadership to product development teams for both hardware and software.

  • Lead Design Control and Risk Management activities (plans, hazard analyses, dFMEA/pFMEA, RMF reports).

  • Oversee and approve Design History File (DHF) documentation, including design inputs/outputs, V&V, and test planning/protocols.

  • Serve as Software Quality SME — guiding code reviews, software security analysis, and software BOM.

  • Lead implementation of software quality bes...

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