Product Systems Engineer - Class II / III Devices

System Validation Engineer

Raleigh, NC (Hybrid Onsite)

Contract | 11 Months | W2

Shape the Future of Patient Care

We are looking for a highly experienced Senior Systems Validation Engineer to join our Software Engineering organization supporting our Infusion Pump Platforms . In this role, you'll provide technical leadership, drive system-level innovation, and ensure our products meet regulatory standards while improving the lives of millions of patients.

You will be involved in the full product lifecycle—from architecture and development through verification, design transfer, and sustaining engineering—collaborating with cross-functional teams to deliver reliable, life-saving technology.

Key Responsibilities

• Serve as a technical leader , mentoring engineers and guiding architectural decisions
• Drive software systems development best practices across product lifecycles
• Translate user needs into system and software requirements
• Lead risk analysis and mitigation for software in regulated medical devices
• Define verification strategies ensuring full requirements traceability
• Participate in software design reviews for new features and sustaining projects
• Support Agile planning and execution , including backlog and schedule management
• Partner with Manufacturing, Service, and Training teams for effective design transfer
• Ensure compliance with regulatory and quality system requirements

Required Qualifications

Why This Role?