Systems Engineer - Verification
Intellectt INC
Title: Systems Engineer Verification
Location: Pleasanton, CA
Duration: 12+ Year
Pay Rate: $48 $50/hr W2
Industry: Medical Device
Seeking an experienced Systems Engineer to lead system-level verification of complex medical devices involving hardware, embedded software, mobile applications, wireless connectivity, and cloud-connected services.
Responsibilities:
- Lead system-level verification planning, execution, and reporting.
- Develop verification strategies, protocols, test methods, acceptance criteria, and traceability matrices.
- Review system requirements for completeness, testability, and traceability.
- Execute functional, performance, safety, and reliability verification testing.
- Maintain traceability between requirements, risk controls, and verification evidence.
- Lead defect investigation, root cause analysis, and verification of corrective actions.
- Support design reviews, risk-control verification, regulatory submissions, design transfer, and sustaining activities.
Qualifications:
- Bachelor's with approximately 5 6 years or Master's with 4+ years of relevant experience.
- Strong experience in Systems Engineering, System Verification, Requirements Engineering, Traceability, and Test Design.
- Experience with complex hardware/software products in a regulated environment; medical device experience strongly preferred.
- Knowledge of Design Controls, Risk Management, Configuration Management, and Change Control.
- Experience with DOORS, JIRA, or similar requirements/defect management tools.
- Familiarity with IEC 62304, IEC 60601, and ISO 14971 preferred.
- Class II/III medical device, embedded firmware, Bluetooth/Wi-Fi, mobile, cloud, cybersecurity, and automated testing experience is a plus.
Vacancy posted 2 days ago
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