Systems Engineer

Job Summary

Serving as the technical lead for system-level integration and traceability during DHF gap assessments, the contract Systems Engineer will ensure completeness and consistency of Design Inputs, Design Outputs, Verification & Validation, and Risk Management across hardware, software, and subsystems for 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
• Collaborate with cross-functional teams to maintain design control consistency and resolve integration issues

Required qualifications

• Strong experience in Systems Engineering, Biomedical Engineering, or a related technical discipline
• Experience in medical device development, including design controls and traceability
• Knowledge of ISO 13485, 21 CFR 820, ISO 14971, and requirements management tools
• Experience with risk management and V&V planning for complex electro-mechanical or software-enabled devices
• Excellent analytical and documentation skills with prior remediation or gap assessment experience preferred