Systems Engineer – Verification

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.