Systems Engineer

Remote-US
G&A – Business Strategy /
Full-Time /
Remote

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Located in the US

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Systems Engineer Experience

  • Do you have 5+ YOE in systems engineering for regulated medical devices or software as a medical device (SaMD)?
  • Do you have knowledge of FDA, EU MDR, and ISO regulations, including IEC 62304, ISO 14971, IEC 62366, and ISO 13485?
  • Can you walk through a time when you led systems engineering activities for a regulated medical device or SaMD product, and explain how you ensured compliance with FDA/EU regulations while collaborating across technical and non-technical teams?