Experienced Systems Engineer (Human Factors) & RA/QA Professional with a track record of delivering successful projects in the Medical Devices industry for over 7+ years. Skilled in System design and architecture, Systems Thinking, Requirements Engineering, Risk Management, Verification & Validation, implementation of various management systems, regulatory compliance, auditing, Human Factors Engineering, Project Management.Expertise in NPI, EU MDR, US FDA, ROW regulatory submissions, DHF remediation, various management systems implementation& audit, and design changes. Adept at verifying and validating processes for top-quality results and regulatory compliance. A collaborative team player who consistently exceeds customer expectations with exceptional technical deliverables. An independent problem-solver with a quick adaptability to new challenges.