Cube Hub Inc. · 13 hours ago
Principal Software System Engineer - Medical Device
Raleigh, NC
Contract
Hybrid
Lead/Staff
$70/hr - $80/hr
10+ years expCube Hub Inc is seeking a Senior Principal Software Systems Engineer to develop innovative healthcare solutions for connected Infusion Pump Platforms. The role involves driving best practices in software systems development, leading cross-functional teams, and ensuring compliance with regulatory standards.
Human ResourcesRecruitingService Industry
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
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 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
Benefits
401(k)
Dental insurance
Health insurance
Referral program
Vision insurance
Company
Cube Hub Inc.
We are a women-owned minority business enterprise at the forefront of talent management solutions.
201-500 employees
H1B Sponsorship
Cube Hub 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 (1)
2024 (2)
2021 (1)
Funding
Current Stage
Growth StageCompany data provided by crunchbase