System Engineer

United Pharma is seeking an experienced Systems Engineer to support the development of innovative medical device products. In this role, you will drive the implementation of strong design control processes, ensuring product development aligns with regulatory and quality standards.

Responsibilities:

• Lead and manage design control activities across the medical device development lifecycle
• Ensure full traceability from user needs through design inputs, verification, and validation
• Maintain and support Design History Files (DHFs) in compliance with regulatory requirements
• Collaborate with hardware, software, and quality teams to ensure seamless system integration
• Ensure adherence to FDA regulations (21 CFR 820) and ISO 13485 quality standards

Requirements:

• 5–8 years of experience in Systems Engineering within a regulated industry
• Strong knowledge of design controls, DHF management, and system lifecycle processes
• Experience working with cross-functional engineering and quality teams
• Prior experience in the medical device industry is strongly preferred