Systems Engineer Verification Engineer

Katalyst Healthcares & Life Sciences; Pleasanton (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Creative Solutions Services, LLC seeks an experienced Systems Engineer – Verification Engineer to lead system-level verification for complex hardware-software medical devices in a regulated environment. You will own verification planning, test design, and cross-functional collaboration.

Responsibilities include developing verification plans and reports, ensuring traceability from requirements to test results, supporting risk management, design controls, and regulatory submissions.

Qualifications

• Bachelor's or Master's degree in a technical field with 4–6+ years of relevant experience.
• Hands-on experience leading system-level verification efforts for complex hardware-software products.
• Experience developing verification plans, protocols, test methods, and verification reports.

Responsibilities

• Lead and execute system-level verification and validation activities for complex hardware-software products.
• Develop and maintain verification plans, protocols, test methods, test cases, and verification reports.
• Review and analyze system requirements for clarity, testability, traceability, and verifiability.
• Establish and 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 cross-functional teams across Systems, Software, Hardware, Quality, Regulatory.
• Identify, document, investigate, and manage verification defects and test failures.
• Support risk management activities including verification of risk controls and mitigations.
• Ensure verification activities comply with design controls, quality system procedures, and regulatory requirements.
• Support configuration management, change management, and impact assessments for product and verification changes.
• Maintain verification documentation and technical records; review test results and prepare verification reports.
• Support regulatory submission activities for Class II and Class III devices.

Skills

Requirements engineering

Verification planning

Test execution

Risk management

Design controls

Education

Bachelor's degree in related field

Master's degree in related field

Job description

Job Summary

We are seeking an experienced Systems Engineer – Verification Engineer to lead and execute system-level verification activities for complex hardware-software products in a regulated product development environment. The ideal candidate will have strong expertise in requirements engineering, verification planning, test execution, risk management, and design controls, preferably within the medical device industry.

Roles and Responsibilities

• Lead and execute system-level verification and validation activities for complex hardware-software products.
• Develop and maintain verification plans, protocols, test methods, test cases, and verification reports.
• Review and analyze system requirements to ensure they are clear, testable, traceable, and verifiable.
• Establish and 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 with requirements.
• Collaborate with Systems, Software, Hardware, Quality, Regulatory, and other cross-functional teams throughout the verification lifecycle.
• Identify, document, investigate, and manage verification defects and test failures.
• Perform or support root-cause analysis, corrective actions, and issue resolution.
• Support risk management activities, including verification of risk control measures and mitigation strategies.
• Ensure verification activities comply with applicable design controls, quality system procedures, and regulatory requirements.
• Support configuration management, change management, and impact assessments associated with product and verification changes.
• Maintain accurate and complete verification documentation and technical records.
• Review test results and prepare comprehensive verification reports and technical documentation.
• Support regulatory submission activities for Class II and Class III medical devices, including preparation and review of verification evidence.
• Independently manage verification deliverables, schedules, priorities, and technical issues.
• Communicate verification status, risks, issues, and technical findings to project teams and stakeholders.
• Participate in design reviews, requirements reviews, risk reviews, and other product development activities.
• Ensure verification activities are conducted in accordance with approved procedures, protocols, and applicable standards.

Education & Experience

• Bachelor's degree in systems engineering, Biomedical Engineering, Electrical Engineering, Software Engineering, Computer Science, or a related technical field with 5–6 years of relevant experience; OR
• Master's degree in systems engineering, Biomedical Engineering, Electrical Engineering, Software Engineering, Computer Science, or a related technical field with a minimum of 4 years of relevant experience.

• 4–6+ years of relevant experience in systems engineering, verification engineering, systems testing, or a related discipline.
• Demonstrated experience leading system-level verification efforts for complex hardware-software products.
• Hands-on experience developing verification plans, protocols, test methods, test cases, and verification reports.