Lead System Verification Engineer

Job Requirements

Lead Engineer - System Verification (Medical Devices)

Role Summary

Lead verification and validation activities for medical device products throughout product development and lifecycle management. Responsible for verification strategy, test planning, execution, data analysis, reporting, and ensuring compliance with global medical device standards, regulatory requirements, and quality systems.

Key Responsibilities

• Develop and execute verification and validation plans, protocols, traceability matrices, and test reports.
• Translate system, subsystem, hardware, software, and user requirements into comprehensive verification activities.
• Design, develop, and validate test methods, fixtures, automated test setups, and laboratory tools.
• Perform functional, performance, reliability, environmental, interoperability, and regression testing.
• Analyze test results using statistical methods (DOE, MSA, Gauge R&R, Minitab) and generate objective evidence supporting compliance.
• Lead system-level verification of design changes and product enhancements throughout the product lifecycle.
• Support risk-based verification activities aligned with ISO 14971 and product risk management processes.
• Collaborate with Systems, Software, Hardware, Quality, Regulatory, and Manufacturing teams to ensure successful product verification and release.
• Mentor engineers and drive best practices in verification methodologies, documentation, and compliance.

EMC/EMI & Electrical Safety

• Lead and support EMC/EMI verification and compliance activities in accordance with IEC Standards.
• Experience with Radiated & Conducted Emissions, ESD, EFT, Surge, RF Immunity, and Magnetic Field Immunity testing.
• Support pre-compliance testing, certification activities, and resolution of EMC-related issues.
• Perform verification activities related to IEC 60601-1 Electrical Safety and Essential Performance requirements.
• Interface with external certification agencies and test laboratories (UL, TÜV, Intertek, DEKRA, CSA, etc.).

Qualifications

• Bachelor's or Master's degree in Electrical Engineering, Electronics, Mechatronics, Biomedical Engineering, Systems Engineering, or related discipline.
• 7-10+ years of experience in Verification & Validation, Test Engineering, or System Verification within the Medical Device industry.
• Strong understanding of Design Verification, Validation, Design Controls, and requirements traceability.
• Hands-on experience with laboratory instrumentation including oscilloscopes, multimeters, power analyzers, DAQs, environmental chambers, and automated test systems.
• Experience with medical device regulations and standards including FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366, and EU MDR.
• Strong analytical, troubleshooting, technical writing, documentation, and stakeholder management skills.

Preferred Qualifications

• Experience with patient monitoring, imaging, diagnostics, therapeutic, infusion, or capital medical equipment.
• Knowledge of LabVIEW, Python, MATLAB, or automated test frameworks.
• Experience supporting sustaining engineering, remediation, design changes, and lifecycle management programs.
• Proven ability to lead verification teams and mentor engineers in regulated medical device environments.