Company:A Large Global Organization
Key Skills: Mechanical Design, System Integration, Verification & Validation (V&V;), Risk Management, Product Design, IQ/OQ/PQ, Medical Devices, QMS
Roles & Responsibilities:
Lead product design verification and validation activities across the product development lifecycle.
Execute system integration and verification activities to meet product requirements, safety, quality, and regulatory standards.
Create and execute test protocols independently as per GDP/GMP guidelines.
Support change control activities, label verification, design verification, and product documentation.
Perform equipment qualification activities including IQ/OQ/PQ and support test report reviews.
Design and support fixtures, testing methods,
and vendor coordination for V&V; activities.
Experience Required:
4-6 years of experience in mechanical engineering and product verification/validation.
Robust experience in mechanical design of electro-mechanical, plastic, or connector-based products.
Hands-on experience with system integration and V&V; test execution.
Knowledge of risk management and reliability testing.
Experience with equipment qualification processes (IQ/OQ/PQ).
Exposure to medical device product development and regulatory requirements is preferred.
Education: Any Graduation