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Staftonic LLC · 9 hours ago

Principal Software Systems Engineer

North Carolina, United States

Contract

Onsite

Lead/Staff

10+ years exp

Staftonic LLC is seeking a Principal Software Systems Engineer to lead the software systems engineering lifecycle for digital applications connected to infusion pump platforms. The role involves translating user needs into system requirements, driving risk management activities, and providing technical leadership throughout the product lifecycle.

Information Technology & Services

Hiring Manager

Shaik Aleem

Responsibilities

Lead the software systems engineering lifecycle for digital applications connected to infusion pump platforms

Translate clinical, commercial, and user needs into clear, traceable system and software requirements

Decompose system requirements into software and subsystem specifications

Drive risk management activities for software and digital platforms, including hazard analysis, FMEA, and mitigation tracking

Define verification and validation strategies, ensuring full requirements traceability from design through testing

Participate in and lead software architecture and design reviews

Provide technical leadership and mentorship to software, systems, and verification engineers

Collaborate with clinical, regulatory, quality, manufacturing, and service teams throughout the product lifecycle

Support Agile development processes, including backlog grooming, feature definition, and sprint planning

Ensure compliance with FDA, ISO, IEC, and internal quality systems

Support design transfer to manufacturing, service, and customer training teams

Drive continuous improvement of processes, tools, and best practices for software systems development

Qualification

Requirements managementRisk managementSystem-level designAgile developmentMedical device engineeringRegulated environment experienceTechnical writingCommunication skills