Medical Device Integration Engineer

Job Summary

To ensure comprehensive system-level integration and traceability, the contract Medical Device Systems Integration Engineer will lead gap assessments, develop specifications, and support verification and validation processes while collaborating with cross-functional teams.

Key responsibilities

• Conduct comprehensive gap assessments of system requirements and traceability matrices
• Develop or remediate system-level specifications and risk analyses
• Identify and resolve integration issues between subsystems during remediation activities

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 devices
• Excellent analytical and documentation skills; prior remediation or gap assessment experience preferred