DivIHN Integration Inc · 16 hours ago
Senior Principal Software Systems Engineer
Raleigh, NC
Contract
Hybrid
Senior Level, Lead/Staff
10+ years expDivIHN Integration Inc is focused on developing innovative healthcare solutions within Connected Infusion Pump Platforms. The Senior Principal Software Systems Engineer will drive best practices in software systems development, act as a technical leader, and collaborate with cross-functional teams to ensure compliance with regulatory and quality standards.
ConsultingInformation TechnologySoftware
Hiring Manager
Vijay Raj
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
Qualification
Required
Bachelor's degree in an Engineering discipline
10+ years of relevant experience in software systems engineering
Subject matter expertise in requirements management and risk management for complex, medically regulated, connected/interoperable system of systems
Experience with development in an agile environment with experience creating and maintaining product backlogs
Excellent oral and written communication skills
Excellent documentation skills
Preferred
Experience with Digital Applications (SaMD. MDDS) connected to regulated electro-mechanical devices in a clinical environment
Experience in a regulated industry
Company
DivIHN Integration Inc
DivIHN (‘Divine’) has served as a holistic Technology Consulting entity since 2002, committed to Client Success & Transformation.
51-200 employees
H1B Sponsorship
DivIHN Integration Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (7)
2022 (4)
2021 (2)
2020 (3)
Funding
Current Stage
Growth StageLeadership Team
Herald Ignatius Manjooran
Founder and CEO
J
John Sinkus
Senior Advisor
Company data provided by crunchbase