Design Quality Engineer – SaMD Compliance & ISO Lead

Heidi is seeking a Design Quality & Compliance Engineer to join our team and ensure software design aligns with global medical device standards in an agile environment. You will work within Engineering while reporting to Legal & Regulatory Affairs to maintain compliance across the software lifecycle.

The role focuses on implementing IEC 62304, ISO 14971, and ISO 13485 controls, risk management, and documentation.

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