Test Engineer - Cincinnati, United States - iRiS Recruiting Solutions

Description

• Responsible to the project team as subject matter expert in verification and validation of medical devices. Lead communication and provide issue escalation support to project teams.
• Responsible for conducting physical, functional tests of products. Must have hands-on mechanical experience and enjoy a shop/lab setting. Manual, mechanical labor will constitute up to 50% of role.
• Develop test plans for medical devices. Regularly generates complex data using spreadsheets, researches the literature as a means to justify testing parameters and evaluate designs.
• Author test reports for medical devices. Regularly analyzes data for statistical evaluations to draw conclusions.
• Coordinate with outside test houses for test scheduling, methods, acceptance criteria, results analyses, and reporting. Attend testing to witness and ensure appropriateness to project team needs.
• Responsible for developing new test methodologies where appropriate to best verify and validate both on-market products and R&D prototypes. Regularly troubleshoot, diagnose, and repair existing test equipment. Design and fabricate fixtures to aid in testing.
• Work with engineering, quality and regulatory to ensure products maintain certification to various standards. Ability to quickly gain an understanding of complex medical device standards; enjoy researching details and minutiae.
• Multiple project track record of test activities accountable to business for program success a plus. NPI experience a plus.
• Exposure to and/or basic engineering understanding of design principles related to electrical assemblies, electro-mechanical/hydraulic devices, motors, control systems, test equipment and data collection, instrumentation and calibration, wiring harnesses, metalworking, machining.
• Exposure and/or basic understanding of medical devices a plus.
• Experience with Solidworks a plus.
• Ability to read and analyze engineering drawings, interpret professional journals, technical procedures, and government standards and regulations.