Oracle
Software Developer 5
Job Description
The Enterprise Architect for Medical Device Software is a senior individual contributor responsible for defining and governing the software architecture and compliance framework for regulated medical devices. This role bridges product development, regulatory, and enterprise architecture functions—ensuring that device software solutions are designed securely, maintain regulatory compliance, and align with enterprise standards and long-term technology strategy.
You will guide product teams in interpreting and applying medical device standards (including IEC 62304, IEC 82304, and FDA guidance), define software interfaces, manage traceability across the system lifecycle, and support the adoption of compliant SDLC processes and tooling.
Deep understanding of medical device software regulations and standards along with a proven experience defining and building secure, complaint and scalable architectures for safety-critical systems is a must.
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