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