System Engineer

United Pharma is seeking a Systems Engineer with strong experience in Medical Device product development to support design control processes and ensure compliance in a regulated environment.

Responsibilities:

• Manage design control activities for medical device development
• Ensure traceability from user needs to verification & validation
• Maintain Design History Files (DHF) and system documentation
• Collaborate with hardware, software, and quality teams
• Ensure compliance with FDA 21 CFR 820 and ISO 13485

Requirements:

• 5–8 years of Systems Engineering experience in Medical Devices
• Strong knowledge of medical device design controls and DHF
• Experience working in FDA-regulated environments
• Ability to collaborate with cross-functional engineering teams