Job Description :
Coordinate and communicate between V&V team and other departments Compose reports and make adjustments to equipment or processes that require improvement Responsible for assuring projects meet customer expectations, and regulatory requirements Provide guidance to engineering staff and other personnel and ensure that design control requirements and being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, and design review Provides input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested. Review DHF for accuracy and completeness and provide guidance on FDA compliance and procedures Create processes and process improvements to ensure consistent implementation of internal requirements and external regulations and standards Assist in the development and maintenance of company procedures for design control, change management, risk management, test method validation, process validation and related areas of the quality management system Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices Perform white box testing on medical device systems. Requirements Bachelor?s or Master?s in Electrical Engineering or similar degree is highly preffered. MUST have experience with medical device systems level testing (dialysis experience highly preferred) MUST have experience with systems or sub-sytems level testing (experience with electrical testing or engineering is preferred) MUST have experience with writing test automation scripts or a background in development Thorough understanding of FDA Quality System regulations in relation to computer system validation Familiar with critical elements of the design history file including risk management, design verification and validation tests and ensuring compliance of these elements to procedural requirements Ability to multi-task and operate within a fast-paced environment Excellent oral, written, analytical, computer and interpersonal skills Functional Testing Experience Proactive Individual who is self-motivated and confident

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