Senior Principal Software Systems Engineer

13 hours ago


Raleigh, North Carolina, United States DivIHN Integration Inc Full time

About the Role

As a Senior Principal Software Systems Engineer, you will play a critical role in developing innovative healthcare solutions within Connected Infusion Pump Platforms. You will support both development and sustaining activities while ensuring compliance with regulatory and quality standards in a highly regulated medical environment.

Responsibilities

  • Drive implementation of best practices in software systems development and product lifecycle management.
  • Act as a technical leader, providing guidance, mentorship, and feedback to engineering teams.
  • Develop and deliver high-quality technical solutions to complex system-level problems under tight timelines.
  • Collaborate with cross-functional teams (Commercial, Clinical, Manufacturing, Service) to:
  • Capture and document user needs
  • Translate user needs into system and software requirements
  • Lead decomposition of system requirements into software subsystem requirements.
  • Lead risk analysis activities for Digital Applications software, including hazard identification and mitigation.
  • Partner with verification engineers to define verification and validation strategies using requirements traceability.
  • Participate in software design reviews for components and features.
  • Support Agile development activities including backlog grooming, feature definition, and sprint execution.
  • Drive collaboration with internal and external stakeholders while promoting improved processes and technical excellence.
  • Support design transfer activities and interface with manufacturing, service, and training teams.
  • Ensure compliance with product development processes and quality systems.

Qualifications

  • Bachelor's degree in an Engineering discipline
  • 10+ years of relevant experience in software systems engineering

Required Skills

  • Subject matter expertise in requirements management and risk management for complex, medically regulated, connected/interoperable system of systems
  • Bachelor's degree in an engineering discipline with 10 + years of experience.
  • Experience with Digital Applications (SaMD. MDDS) connected to regulated electro-mechanical devices in a clinical environment preferred.
  • Experience with development in an agile environment with experience creating and maintaining product backlogs.
  • Excellent oral and written communication skills.
  • Experience in a regulated industry preferred.
  • Excellent documentation skills.

Equal Opportunity Statement

We are committed to diversity and inclusivity in our hiring practices and encourage applications from all qualified individuals.



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