Responsibilities: BS Engineering and + years of experience. Drawing and Specification reviews. Manufacturing Process Control Plan reviews. Measurement System Analysis (MSA), Test Method Validation (TMV) reviews. Manufacturing process validation reviews. Manufacturing process capability assessment. Manufacturing Experience in a highly regulated environment. Risk Management- Medical. Requirements: BS Engineering (EE preferred) and + years of experience. Design History File Audit and Management. Test Cases/Protocols/Report review and approve. Drawing and specification reviews. Design Control in a highly regulated industry. Hardware Verification and Validation. Testing Methodologies.