Ar Val Services - Santa Rosa, CA
posted 3 months ago
The Senior Hardware Verification/Test Engineer will play a critical role in ensuring the functionality and compliance of medical device hardware components. This position involves performing comprehensive hardware functional verification and testing to validate that products meet the required specifications and standards. The engineer will be responsible for developing and updating hardware test protocols tailored for medical devices, ensuring that all testing procedures are robust and effective. Additionally, the role requires conducting thorough reviews and approvals of design specifications for both new and existing medical devices, ensuring that all designs adhere to regulatory and quality standards. A significant aspect of this position is the identification and validation of alternative components to address obsolescence issues in medical device hardware. The engineer will collaborate closely with cross-functional teams, including design, regulatory, and quality assurance, to ensure that all products comply with necessary regulatory standards and quality requirements. The engineer will also contribute to risk analysis and management processes, providing insights and technical expertise throughout the product development lifecycle. The role includes conducting IEC 60601 and other certification testing for medical electrical equipment, ensuring that all products meet the necessary safety and performance standards. This position is essential for maintaining the integrity and reliability of medical devices, ultimately contributing to patient safety and product efficacy.