Lead Systems Engineer, Medical Devices Regulatory Melbourne

Lead Systems Engineer, Medical Devices Regulatory Melbourne

31 Aug
|
ProFound People
|
Melbourne

31 Aug

ProFound People

Melbourne

Profound People is seeking a Lead Systems Engineer in Melbourne to guide the medical device development from concept to manufacturing. You will own the system architecture, requirements management, and design controls across the V model, ensuring traceability and regulatory alignment.

You will lead risk management per ISO 14971, coordinate cross-disciplinary input, and guide FDA pathways and IEC/ISO standards, enabling successful regulatory submissions and production readiness.
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📌 Lead Systems Engineer, Medical Devices Regulatory Melbourne
🏢 ProFound People
📍 Melbourne

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