Responsibilities:BS Engineering and 2+ 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 2+ 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.