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:
- Bachelors degree in Engineering with 5 years of experience OR
Masters 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
Regards
Jitendra Kumar Shakya
Senior Talent Acquisition Specialist
Wise Equation Solutions Inc.
(Service-Disabled Veteran-Owned Company)
Office : Ext: 124
Email:
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 distri...
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:
- Bachelors degree in Engineering with 5 years of experience OR
Masters 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
Regards
Jitendra Kumar Shakya
Senior Talent Acquisition Specialist
Wise Equation Solutions Inc.
(Service-Disabled Veteran-Owned Company)
Office : Ext: 124
Email:
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