Develops new technology, products, materials, processes, or equipment with minimal supervision. Develop product requirements Designs, develops, debugs, modifies, and tests electrical, software and imaging design solutions by using current tools, analysis techniques, and technologies Review electrical, mechanical and optical designs and changes to ensure development of appropriate test methods Define strategy and perform product design and testing that will comply with electrical safety standards and medical device regulations Develop and execute test methods and fixtures for design verification Define and execute test plans to support design verification Work closely with Mechanical, Electrical and Optical Engineers to develop opto-electromechanical test methods Provide electronic and system level troubleshooting of prototype devices to aid product development Work as a “hands-on” Engineer in performing troubleshooting on new products/process problems as related to design, material, or process. Conduct feasibility studies to verify capability and functionality or to assess existing technologies Solve complex problems and make sound design recommendations Summarize, analyze, and draw conclusions from complex test results Prepare complex reports and communicate results a wide range of audiences Responsible for engineering documentation Proactively builds relationships and collaborates with cross-functional partners to ensure technical deliverables meet stakeholder needs Identifies and builds relationships with external device manufacturers Candidate require process at least Bachelor's degree in Biomedical Engineering, Electrical Engineering or related field (computer, software, systems) At least 8 years in product development Proficient with electrical engineering principles In depth knowledge of design verification for a regulated industry Proficiency with lab equipment including power supplies, oscilloscopes, multimeters, spectrum/signal/logic analyzers Effective communications/presentation skills to all levels of the organization (both written and verbal) Experience working within Design Controls or equivalent for Medical Device Industry Electrical safety (IEC 60601-1), HF (IEC 60601-2-2) and EMI/EMC (60601-1-2) standards experience 10-20% travel, including international Medical device experience Master's or Ph.D degree in Biomedical Engineering, Electrical Engineering or related field (computer, software, systems) Clinical and technical knowledge of imaging based medical devices Proficient with optical and/or bioinstrumentation principles
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