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Product Systems Engineer - Class II/III Devices
Product Systems Engineer - Class II/III DevicesSwoon • Raleigh, NC, US
Product Systems Engineer - Class II / III Devices

Product Systems Engineer - Class II / III Devices

Swoon • Raleigh, NC, US
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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

  • Bachelor's degree in Engineering or related field (Master's preferred)
  • 10+ years of experience in software systems engineering
  • Experience with electro-mechanical or embedded medical devices
  • Knowledge of regulated industry standards such as IEC 62304, ISO 13485, and risk management
  • Strong communication and documentation skills
  • Proven ability to deliver high-quality solutions on tight timelines

    • Why This Role?

  • Work on life-critical healthcare technology
  • Lead initiatives with high technical and organizational impact
  • Opportunity to improve device safety and enhance patient outcomes
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