Systems Engineer Medical Device | Remote

We are seeking experienced Systems Engineers to support 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 Support V&V planning and traceability matrix updates Resolve subsystem integration and design control gaps Collaborate with Hardware, Software, Quality, Clinical, Regulatory, and Manufacturing teamsRequired 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 Strong documentation and remediation experiencePreferred: DHF Remediation projects Gap Assessment experience Electro-mechanical and Software-enabled Medical DevicesInterested candidates can message me directly or send their updated resume.