Senior Systems Engineer

Job Summary

Seeking a remote contract Senior Systems Engineer with over 10 years of medical device experience who will manage design controls, ensure compliance with FDA regulations, and drive continuous improvement initiatives.

Key responsibilities

• Manage systems engineering processes related to medical device development
• Oversee design verification and validation activities to ensure product compliance
• Maintain and enhance documentation for design history files (DHF) and traceability

Required qualifications

• 10+ years of experience in systems engineering within the medical device industry
• Proficiency in FDA 21 CFR 820 and ISO 13485 standards
• Experience with DOORS and Polarion for requirements management
• Strong background in design controls and traceability processes
• Knowledge of continuous improvement methodologies