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Systems EngineerVirtualVocations • Hollywood, Florida, United States
Systems Engineer

Systems Engineer

VirtualVocations • Hollywood, Florida, United States
30+ days ago
Job type
  • Full-time
Job description
Serving as the technical lead for system-level integration, the full-time Systems Engineer will conduct gap assessments, develop documentation, and support verification and validation processes for complex medical devices. Key responsibilities Conduct comprehensive gap assessments of system requirements, architecture, and traceability matrices Develop or remediate system-level specifications, interface documents, and risk analyses for compliance Support the creation or updating of verification and validation master plans to ensure full coverage Required qualifications Strong experience in Systems Engineering, Biomedical Engineering, or a related technical discipline within medical device development Solid understanding of medical device design controls and end-to-end traceability frameworks Strong working knowledge of ISO 13485, 21 CFR 820, and ISO 14971 Experience with risk management and verification and validation planning for complex devices Excellent analytical and documentation skills, with prior experience in remediation or gap assessments preferred
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Systems Engineer • Hollywood, Florida, United States

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