Stefanini Group · 6 hours ago
Senior System Software Engineer
Raleigh, NC
Contract
Hybrid
Senior Level, Lead/Staff
$78/hr - $78/hr
10+ years expStefanini Group is seeking a Senior Principal Software Systems Engineer to develop innovative healthcare solutions for connected Infusion Pump Platforms. The role involves leading software systems development, collaborating with cross-functional teams, and ensuring compliance with regulatory standards.
Management Consulting
Hiring Manager
Rachit Rastogi
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 who provides 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 to improve processes, practices, and technical mentorship
Interface with manufacturing, service, and customer training staff through the design transfer process
Ensure compliance with 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 engineering discipline with 10 + years of experience
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 is preferred
Experience with development in an agile environment with experience creating and maintaining product backlogs
Experience in a regulated industry preferred
Benefits
00 PTO
Company
Stefanini Group
Global Tech Consulting Company All in One. Stefanini is a Brazilian multinational company with 37 years of experience and presence in 41 countries.
10001+ employees
Funding
Current Stage
Late StageCompany data provided by crunchbase