Principal Software Systems Engineer

Senior Software Systems Engineer Medical Devices

Raleigh NC (Onsite)
12-Month Contract
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This is where your work saves lives.

We are seeking a Senior Principal Software Systems Engineer to lead the development of connected digital applications within Infusion Pump Platforms. This is a senior hands-on technical leadership role responsible for system architecture requirements risk management and regulatory compliance in a highly regulated medical environment.

Key Responsibilities

Technical Leadership & System Development

• Drive best practices in software systems development and product lifecycle management.

• Act as a technical leader and mentor providing guidance and feedback to engineering teams.

• Develop high-quality scalable solutions to complex system-level software challenges.

• Participate in and lead software design reviews for major components and features.

Requirements & Risk Management

• Lead collaboration with Commercial Clinical and Cross-Functional teams to:

  • Capture user needs

  • Translate them into system and software requirements

• Decompose system requirements into software subsystem requirements.

• Lead risk management activities including:

  • Hazard identification

  • Risk analysis

  • Mitigation implementation and traceability

Verification Validation & Compliance

• Partner with verification engineers to define test strategies V&V plans and traceability.

• Ensure compliance with quality systems regulatory standards and product development processes.

• Support design transfer activities with manufacturing service and training teams.

Agile & Stakeholder Collaboration

• Lead product backlog creation grooming and feature definition in an Agile environment.

• Drive collaboration with internal and external stakeholders.

• Promote continuous improvement in processes tools and engineering practices.

Required Qualifications

• Bachelors degree in Engineering or related discipline.

• 10 years of experience in software systems engineering.

• Strong expertise in:

  • Requirements management

  • Risk management

  • System-of-systems architectures

• Experience working in a regulated industry (medical devices preferred).

• Excellent written and verbal communication skills.

• Strong documentation and technical leadership capabilities.

Preferred Experience

• Digital Applications including SaMD / MDDS.

• Connected or interoperable systems tied to electro-mechanical medical devices.

• Clinical environment exposure.

• Agile development with experience managing and maintaining product backlogs.