Lead Systems Verification Engineer (Medical Devices)

Katalyst CRO; Pleasanton (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Katalyst CRO is seeking an experienced Systems Engineer Verification Engineer to lead system-level verification activities for complex hardware-software products in a regulated development environment.

The role focuses on requirements engineering, verification planning, test execution, risk management, and design controls, with close collaboration across Systems, Software, Hardware, Quality, and Regulatory teams.

Qualifications

• Bachelor's degree in a related technical field with several years of relevant experience.
• Master's degree with minimum several years of relevant experience.
• Experience leading system-level verification efforts for complex hardware-software products.

Responsibilities

• Lead and perform system-level verification and validation for complex hardware-software products.
• Develop verification plans, protocols, test methods, and verification reports.
• Review requirements to ensure they are clear, testable, traceable, and verifiable.
• Maintain requirements traceability between system requirements, risk controls, verification procedures, and test results.
• Design and execute system-level tests to verify product functionality, performance, reliability, and compliance.
• Collaborate with Systems, Software, Hardware, Quality, Regulatory, and other cross-functional teams.
• Identify, document, investigate, and manage verification defects and test failures.
• Support risk management activities, including verification of risk controls and mitigation strategies.
• Ensure verification activities comply with design controls and regulatory requirements.
• Support configuration and change management related to verification changes.
• Maintain accurate verification documentation and technical records.
• Review test results and prepare verification reports and supporting documentation.
• Assist regulatory submission activities with verification evidence.

Skills

Requirements engineering

Verification planning

Test execution

Risk management

Regulatory compliance

Education

Bachelor's degree in related field

Master's degree in related field

5+ years of systems engineering experience

Job description

Katalyst CRO is seeking an experienced Systems Engineer Verification Engineer to lead system-level verification activities for complex hardware-software products in a regulated development environment.

The role focuses on requirements engineering, verification planning, test execution, risk management, and design controls, with close collaboration across Systems, Software, Hardware, Quality, and Regulatory teams.