Sthavirsoft INC · 19 hours ago
Senior Principal Software Systems Engineer
Raleigh, NC
Contract
Onsite
Senior Level, Lead/Staff
10+ years expIntela Group USA is a company focused on developing connected medical device ecosystems. They are seeking a Senior Principal Software Systems Engineer to drive software systems development best practices, mentor engineers, and lead collaboration across various stakeholders to ensure compliance and effective risk management.
Software Development
Responsibilities
Drive software systems development best practices across product lifecycles for connected medical device ecosystems
Serve as a technical leader, mentoring engineers and providing technical direction and feedback
Architect and deliver high-quality system-level software solutions to complex technical challenges on aggressive schedules
Lead and participate in software and system design reviews
Author and maintain system-level and software-level requirements and design inputs for connected systems, including medical devices integrated with digital and cloud-based applications
Lead collaboration with Commercial, Clinical, and cross-functional stakeholders to capture user needs and translate them into clear, testable system requirements
Drive decomposition of system requirements into software subsystem requirements with full traceability
Author and own risk management deliverables, including hazard analysis, risk assessments, and mitigation tracking, preferably aligned with ISO 14971
Lead end-to-end risk management activities from hazard identification through implementation and verification of risk controls
Ensure alignment between risk controls, system requirements, and verification activities
Partner with Verification Engineers to define verification and validation strategies, including requirements traceability and test coverage
Support development of V&V plans and participate in review of test results
Ensure compliance with product development processes, quality systems, and regulatory standards
Support design transfer activities with manufacturing, service, and customer training teams
Work within Agile software/product development environments, including product backlog creation, grooming, sprint planning, and execution
Drive collaboration across internal and external stakeholders, enabling continuous improvement in processes, tools, and technical practices
Qualification
Required
Bachelor's degree in Engineering or related discipline
10+ years of experience in software systems engineering or related roles
Direct experience authoring system-level and software-level requirements/design inputs for connected systems
Direct experience authoring risk management deliverables, preferably aligned with ISO 14971
Experience working in Agile software/product development environments (backlogs, sprints, incremental delivery)
Excellent oral and written communication skills
Strong technical documentation skills
Experience working in a regulated industry (medical device preferred)
Preferred
Experience with Digital Applications, including SaMD (Software as a Medical Device) and MDDS
Experience with cloud-hosted digital applications integrated with regulated medical devices
Hands-on experience working with or delivering products compliant to: ISO 62304 – Medical device software lifecycle, ISO 82304 – Health software, ISO 13485 – Quality management systems, ISO 14971 – Risk management
Experience with connected/interoperable systems used in clinical environments
Company
Sthavirsoft INC
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2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase