Systems Engineer

Job Summary

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