System Engineer

United Pharma Technologies Inc is a company focused on regulated medical device environments, and they are seeking a Systems Engineer to lead design control activities. The role involves maintaining traceability from user needs through design inputs, collaborating with cross-functional teams, and supporting design verification and validation activities.

Responsibilities:

• Lead design control activities ensuring compliance with FDA 21 CFR 820 and ISO 13485
• Maintain traceability from user needs through design inputs, verification, and validation
• Collaborate with cross-functional teams (hardware, software, quality, regulatory)
• Support design verification & validation (V&V) activities
• Develop and maintain Design History Files (DHF) and design control documentation
• Identify and implement improvements in systems engineering and design control processes

Requirements:

• 5–8 years of systems engineering experience in a regulated/medical device environment
• Strong experience with design controls, requirements management, and traceability
• Knowledge of FDA 21 CFR 820 and ISO 13485 regulations
• Strong documentation, communication, and problem-solving skills