Verification and Validation Engineer Position

Verification and Validation Engineer The Verification and Validation Engineer will be responsible for all activities related to the design verification and design validation. This includes, but is not limited to, defining, planning, documenting, leading, and / or performing all V&V activities. Located in Dallas. Responsibilities Define, plan and lead activities, including, test method development and validation, fixture design and testing optimization in support of Design Verification and Validation. Evaluate and analyze the system (entire device and any peripherals) performance and reliability to ensure the design is adequately pressure-tested to satisfy user, regulatory and business requirements. Understand the system and subsystem design performance to identify and address early in the development process any potential design integration and design transfer risks. Create and document test methodologies and provide feedback and recommendations for product / design changes. Follow the Design Control Process and ensure compliance with the company’s quality policies, procedures, and practices. Develop, document, and verify / validate test tools and test methodology for the verification of hardware (electrical, mechanical, imaging). Write and execute integration, plans, protocols, and associated reports. Write and execute characterization, plans, protocols, and associated reports. Write and execute verification plans, protocols, and associated reports. Write validation plans and protocols and execute validation testing to demonstrate coverage of user needs and intended uses. Analyze information and test data to support technical solutions. Identify, report, and track defects identified throughout all phases of the development lifecycle. Assist in quality systems responsibilities requested by management to ensure a robust and compliant Quality Management System Qualifications Experience developing Class II and / or Class III medical devices. A bachelor’s degree, or an advanced degree, in engineering, biotech, life sciences, or equivalent experience. 5+ years experience in the medical device industry. Working knowledge of the following regulations / standards : 21 CFR 820 and ISO 13485 Risk Management per ISO 14971 All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, age or veteran status.