Systems Engineer

Job Summary

A company is looking for a Systems Engineer to join their growing team.

Key Responsibilities

• Manage requirements engineering, ensuring traceability and clarity throughout the product lifecycle
• Define and document system architecture and design, collaborating with engineering teams
• Lead risk management activities and ensure compliance with regulatory standards

Required Qualifications

• Bachelor's degree in a relevant technical discipline; advanced degree preferred
• 7+ years of experience in systems engineering for regulated medical software
• Experience with Agile or hybrid software development in regulated environments
• Strong background in requirements engineering and systems architecture
• Knowledge of FDA regulations and standards related to medical devices