MyCareernet
Company:
https://www.linkedin.com/company/mycareernet
Seniority: Mid-Senior level
Industries: Medical Equipment Manufacturing, Medical Practices, and Biotechnology Research
Job details:
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.
- Strong 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
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