Medical Device Systems Engineer

Job Summary

Seeking experienced Systems Engineers, the remote contract position will focus on supporting Design History File (DHF) remediation and gap assessment activities for a medical device program.

Key Responsibilities:

• Perform system-level gap assessments across requirements, architecture, traceability, and V&V documentation
• Review Design Inputs, Design Outputs, Verification & Validation, and Risk Management documentation
• Develop or remediate system specifications, interface requirements, and risk analysis documents

Required Qualifications:

• Systems Engineering experience
• Medical Device development background
• Design Controls and Traceability expertise
• Knowledge of ISO 13485, ISO 14971, and 21 CFR 820
• Risk Management and V&V Planning experience