DivIHN Integration Inc · 10 hours ago
Principal Software Engineer
Raleigh, NC
Contract
Hybrid
Lead/Staff
10+ years expDivIHN Integration Inc is focused on developing innovative healthcare solutions. As a Senior Principal Software Systems Engineer, you will lead the development and sustaining activities within connected Infusion Pump Platforms, ensuring compliance with customer needs and regulatory standards.
ConsultingInformation TechnologySoftware
Responsibilities
Drive the implementation of best practices in software systems development and product lifecycles in collaboration with development and verification teams, for Digital Applications that are part of infusion pumps ecosystem
Be a technical leader providing team members guidance and feedback on technical work
Develop technical solutions to complex software system problems and deliver high-quality solutions on tight schedules
Lead efforts with cross-functional team members (e.g. Commercial and Clinical) to document user needs and translate them to user needs into system requirements
Lead decomposition of system requirements into software subsystem requirements
Lead risk analysis activities for Digital Applications software from the capture of inherent hazards through mitigation implementation
Work with verification engineers to define test strategies for the development of verification and validation plans using requirement tracing methods
Participate in software design reviews for components or features
Perform product backlog and feature grooming/definition activities as part of Agile planning/execution
Drive collaboration with internal and external stakeholders and enable the team on better processes, practices and technical mentorship
Interface with manufacturing, service, and customer training staff through the design transfer process
Ensure compliance to the product development process and quality system
Qualification
Required
Bachelor's degree in an engineering discipline with 10 + years of experience
Subject matter expertise in requirements management and risk management for complex, medically regulated, connected/interoperable system of systems
Drive the implementation of best practices in software systems development and product lifecycles in collaboration with development and verification teams, for Digital Applications that are part of infusion pumps ecosystem
Be a technical leader providing team members guidance and feedback on technical work
Develop technical solutions to complex software system problems and deliver high-quality solutions on tight schedules
Lead efforts with cross-functional team members (e.g. Commercial and Clinical) to document user needs and translate them to user needs into system requirements
Lead decomposition of system requirements into software subsystem requirements
Lead risk analysis activities for Digital Applications software from the capture of inherent hazards through mitigation implementation
Work with verification engineers to define test strategies for the development of verification and validation plans using requirement tracing methods
Participate in software design reviews for components or features
Perform product backlog and feature grooming/definition activities as part of Agile planning/execution
Drive collaboration with internal and external stakeholders and enable the team on better processes, practices and technical mentorship
Interface with manufacturing, service, and customer training staff through the design transfer process
Ensure compliance to the product development process and quality system
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
Experience with development in an agile environment with experience creating and maintaining product backlogs
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