Principal Software Systems Engineer - Full-Time

Wise Equation Solutions

Raleigh, United States of America

1 month ago

Role details

Contract type

Permanent contract

Employment type

Full-time (> 32 hours)

Working hours

Regular working hours

Languages

English

Experience level

Senior

Raleigh, United States of America

Testing (Software)

Agile Methodologies

Amazon Web Services (AWS)

Systems Engineering

Azure

Software as a Service

Cloud Computing

Infrastructure as a Service (IaaS)

Platform as a Service (PAAS)

Scrum

Software Architecture

Systems Development Life Cycle

Requirements Management

Requirements Traceability

Software Systems

Verification and Validation (Software)

Drive best practices in software systems development using Agile PDLC/SDLC and Systems Engineering methodologies
Provide technical leadership and mentorship to distributed R&D teams
Develop innovative solutions to complex software system challenges
Contribute to system and software architecture for digital applications
Capture user needs and translate them into functional and non-functional requirements
Lead cross-functional collaboration to integrate requirements into system design
Write and maintain system-level and software-level requirements documentation
Ensure compliance with Quality Management Systems (QMS) and regulatory standards
Lead ISO 14971-based risk management activities
Support verification and validation strategy, including requirement traceability
Conduct ad-hoc software testing to ensure product quality
Support Agile/Scrum planning, estimation, and execution
Collaborate with stakeholders to transform requirements into test architectures
Support design transfer with manufacturing, operations, field service, and training teams
Lead technical investigations related to field issues and product complaints
Ensure compliance with product development and quality system standards

Bachelor's degree in Engineering with 5+ years of experience OR, Master's degree with 3+ years of experience * Experience in regulated industries (medical devices/biotechnology preferred)
Experience with connected systems and digital applications
Strong background in requirements management and risk management
Experience working in Agile environments with backlog management
Knowledge of medical device cybersecurity design (preferred)
Experience with cloud-based applications (AWS, Azure, SaaS/PaaS/IaaS preferred)
Familiarity with electro-mechanical devices (preferred)
Strong documentation, communication, and compliance experience