Senior Verification & Validation (V&V) Engineer

Job Title: Senior Verification & Validation (V&V) Engineer
Industry: Medical Devices
Location: Milpitas, CA onsite

Key Skills: Protocol Writing, Protocol Execution, Validation Reporting, IT Systems, Legacy Systems, ISO 13485

Job Summary

We are seeking a Senior Verification & Validation (V&V) Engineer with experience in the medical device industry to support verification and validation activities in a regulated environment. The ideal candidate will have strong expertise in protocol development, test execution, validation documentation, and report generation, along with experience working with IT systems and legacy technologies, particularly Windows 2000.

The candidate must be self-motivated, detail-oriented, and capable of working independently while ensuring compliance with applicable quality standards and regulatory requirements.

Must-Have Technical/Functional Skills

• Medical device industry experience.
• Strong experience in writing, reviewing, and executing test protocols.
• Hands-on experience in Verification and Validation (V&V) activities.
• Experience preparing validation reports and documenting test results.
• IT systems and application experience.
• Exposure to legacy operating systems, particularly Windows 2000.
• Ability to troubleshoot and work with legacy technologies and systems.
• Knowledge of regulated environments, quality processes, and documentation practices.
• Strong analytical, troubleshooting, and problem-solving skills.
• Excellent written and verbal communication skills.
• Ability to work independently with minimal supervision.

Roles and Responsibilities

• Develop, review, and execute V&V protocols, test plans, and test procedures.
• Perform protocol execution and document observations, deviations, test results, and outcomes accurately.
• Prepare validation reports and ensure complete, accurate, and traceable documentation.
• Support verification and validation activities throughout the medical device product lifecycle.
• Verify that systems and applications meet defined requirements and acceptance criteria.
• Work with legacy systems, applications, and operating environments, including Windows 2000, as required.
• Identify, document, and support the resolution of issues encountered during testing.
• Ensure compliance with applicable quality procedures, regulatory requirements, and organizational standards.
• Collaborate with Engineering, Quality Assurance, and Regulatory Affairs teams.
• Maintain V&V documentation and supporting evidence for audits and compliance reviews.
• Follow established standard operating procedures (SOPs), change control processes, and deviation management practices.
• Manage assigned responsibilities independently while meeting project timelines and quality expectations.

Preferred Qualifications

• Familiarity with FDA regulations applicable to medical devices.
• Knowledge of ISO 13485 Quality Management Systems.
• Understanding of IEC 62304 medical device software lifecycle processes.
• Experience with software validation and IT system validation in regulated environments.
• Knowledge of requirements traceability, risk-based testing, change control, and deviation management.
• Experience supporting quality audits and regulatory inspections.

Essential Skills

• Senior Verification & Validation (V&V) Engineering
• Medical Device Industry Experience
• Protocol Writing and Execution
• Test Planning and Test Execution
• Validation Report Generation
• IT Systems
• Legacy Operating Systems – Windows 2000
• Quality Processes and Regulatory Compliance
• Technical Documentation

Desirable Skills

• ISO 13485
• FDA Medical Device Regulations
• IEC 62304
• Software Verification and Validation
• IT Systems Validation
• Quality Management Systems (QMS)
• Risk Management and Requirements Traceability
• Change Control and Deviation Management

Keywords

Verification and Validation, Medical Device Industry, Medical Device Regulations, Protocol Writing, Protocol Execution, Test Plan Development, Validation Reports, IT Systems, Legacy Systems, Windows 2000, ISO 13485, FDA, IEC 62304, Quality Assurance, Regulatory Compliance, Software Validation, EIS – Medical Device & Regulations.