Lead Systems Verification Engineer - Medical Devices

Intellectt INC; Pleasanton (CA); On-site; USD 66,000 - 69,000; Full time

Job summary

Intellectt INC is seeking an experienced Systems Engineer to lead system-level verification for complex medical devices, including hardware, embedded software, mobile apps, wireless connectivity, and cloud services.

You will drive verification planning, create strategies and validation protocols, and ensure traceability across requirements and risk controls in a regulated environment. Strong DOORS/JIRA experience and IEC 62304/60601 knowledge are highly valued.

Qualifications

• Bachelor's degree with approximately 5–6 years of relevant experience or Master's with 4+ years in systems engineering.
• Experience in a regulated medical device environment preferred.
• Familiarity with design controls and risk management.

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.

Skills

Systems Engineering

System Verification

Requirements Eng

Traceability

Test Design

DOORS

JIRA

IEC 62304

IEC 60601

ISO 14971

Risk Management

Change Control

Configuration Mgmt

Education

Bachelor's degree

Master's degree

Tools

DOORS

JIRA

Job description

Intellectt INC is seeking an experienced Systems Engineer to lead system-level verification for complex medical devices, including hardware, embedded software, mobile apps, wireless connectivity, and cloud services.

You will drive verification planning, create strategies and validation protocols, and ensure traceability across requirements and risk controls in a regulated environment. Strong DOORS/JIRA experience and IEC 62304/60601 knowledge are highly valued.