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Stefanini North America and APAC · 7 hours ago

Sr. Principal Engineer

Raleigh, NC

Contract

Onsite

Senior Level, Lead/Staff

10+ years exp

Stefanini Group is a global provider of IT digital consulting and outsourcing services. They are seeking a Senior Principal Software Systems Engineer responsible for developing innovative healthcare solutions and supporting development activities within connected Infusion Pump Platforms to meet customer needs and regulatory standards.

Information TechnologyOutsourcing

H1B Sponsor Likely

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

Requirements managementRisk managementAgile developmentDigital ApplicationsCommunicationDocumentation

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

Company

Stefanini North America and APAC

Glassdoor3.8

Global Tech Consulting Company All in One. Stefanini is a Brazilian multinational company with 37 years of experience and presence in 41 countries.

Founded in 1987

Kölln-reisiek, Schleswig-Holstein, DEU

10001+ employees

http://www.stefanini.com/EN

H1B Sponsorship

Stefanini North America and APAC 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)

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Trends of Total Sponsorships

2025 (13)

2024 (11)

2023 (13)

2022 (18)

2021 (14)

2020 (12)