Sr. Principal Engineer

Stefanini Group•Raleigh, NC

About The Position

As a Senior Principal Software Systems Engineer in the software organization, you will be responsible for developing innovative healthcare solutions and supporting development and sustaining activities within connected Infusion Pump Platforms to meet customer needs and regulatory standards. What you'll be doing: 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.

Requirements

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.

Nice To Haves

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.

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.