Principal Software Systems Engineer - Full-Time

Role: Principal Software Systems Engineer

Location: Raleigh, NC (Onsite)

Duration: Full-Time

Job Description

Job Responsibilities:

• 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

Qualifications:

• Bachelor’s degree in Engineering: 5+ years of experience OR
• Master’s degree: 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

Regards

Jitendra Kumar Shakya

Senior Talent Acquisition Specialist

Wise Equation Solutions Inc.

(Service-Disabled Veteran-Owned Company)

Office : (512) 410-4425, Ext: 124

Email: Jitendra@wiseq.net