Heidi seeks a Design Quality & Compliance Engineer to ensure software design and development meet global medical device standards (IEC 62304, ISO 14971, ISO 13485) within an agile setting. Reporting to Legal & Regulatory Affairs, you’ll collaborate with Engineering and Product to embed compliance in fast-paced delivery.
You will drive design control, manage technical documentation, risk management files, verification and validation, and audits.
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📌 SaMD Design Quality & Compliance Engineer — Remote + Equity (Australia)
🏢 Health Data Innovations
📍 Australia
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