Masters or foreign equivalent degree in Biomedical Engineering, ElectricalElectronics Engineering, SoftwareComputer Engineering, Systems Engineering, Robotics or in a closely related software or engineering field of study Will accept a Bachelors degree 5 years of progressive professional experience in lieu of a Masters degree each alternative requirement with at least 3 years of systems development or systems engineering experience in i implantable medical device product development; ii documenting systems architecture, software architecture, and designs, including Unified Modeling Language UML diagrams; iii systems integration, verification, and validation activities, generating test plans and report documents, maintaining Master Verification Matrix, reviewing materials with subsystem leads, performing and analyzing system setup, conducting manual and automated verification and validation testing; iv developing risk management activities; v medical device manufacturing industry requirements and regulations, including FDA 21 CFR Part 820, ISO 13485, and ISO 14971; vi programming languages, including C, C, Java, and Python; vii system configuration at integration points, including hardware breadboards, PC hardware system interfaces, embedded systems, and Bluetooth or related wireless communication protocols; and viii medical devices that incorporate electronic, mechanical, and software features. Employer will accept any suitable combination of education, training, or experience.
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