Job Description
• Develop comprehensive validation strategies including test plans, risk-based test coverage, verification matrices, and traceability to requirements.
• Lead complex troubleshooting and root cause investigations of product issues identified during testing, production, or field operation.
• Ensure accurate defect documentation and tracking within bug/defect management systems while driving closure with engineering teams.
• Develop, review, and continuously improve test books, validation methodologies, and test procedures to ensure repeatability and coverage.
• Author and review test procedures, validation plans, regulatory test documentation, and detailed test reports.
• Provide technical leadership for regulatory validation testing and ensure compliance under the CTDP program and other applicable standards.
• Design, develop, and implement complex test setups including hardware fixtures, simulation environments, software tools, and automation frameworks.
• Collaborate closely with R&D, Systems Engineering, Product Management, Manufacturing, and Operations to ensure proper validation coverage and product readiness.
• Provide technical expertise on product architecture, operating systems, and specialized operating environments.
• Lead or contribute to automation initiatives to increase efficiency and repeatability of validation and regression testing.
• Define and improve test processes, methodologies, and validation best practices across the organization.
• Mentor and support junior engineers and technicians in testing methodologies, troubleshooting techniques, and product knowledge.
• Participate in cross-functional design reviews and provide validation input during architecture, design, and development phases.
• Provide risk assessments and timely escalation when validation timelines, quality targets, or project milestones may be compromised.
• Track project validation progress and ensure proper documentation of test coverage, results, and quality metrics.
• Continuously expand product, system, and technology knowledge to support evolving product platforms and architectures.
• Define verification and validation strategies aligned with NPD milestones, ensuring requirements traceability from product requirements through final validation.
