Participate in projects as a direct contributor in support of the design of cataract and vitreoretinal ophthalmic surgical equipment and disposable products.
Support engineering activity for new design, design enhancements, and / or design maintenance on a medical device. Ensure V&V systems are of known and correct configuration in order to collect valid and reliable test data. Support the development effort by utilizing the full capabilities of the Engineering Lab to verify and validate the design as well as provide troubleshooting support as needed.
Configuration Management: Assist with maintaining configuration control of systems, modules and components used for Verification & Validation activities. Maintain configuration records for all equipment under configuration control. Maintain the Device History Record (DHR) for V&V systems. Coordinate the scheduling of V&V systems to support all R&D projects. Work with Engineering & Quality with equipment audits to ensure systems are approved for V&V testing.
Verification and Testing: Assemble/disassemble V&V systems and modules. Build prototype circuits on generic prototype boards or on rapid prototype custom PCBs to existing schematics and BOMS provided by design engineers. Modify existing boards to prototype proposed design changes. Build prototype cables. Build electrical test fixtures. Execute electrical tests and report on results. Author and execute test protocols and engineering studies and complete test reports.
Design Documentation: Author change requests for documentation changes to schematics, assembly BOMS, assembly configuration history documents, and PCB functional tests. Guide packages through the approval process.
Engineering Lab: Maintain Engineering lab area. Maintain calibration of all electronic test equipment. Know how to operate lab test equipment such as oscilloscopes, meters, etc. Operate and maintain R&D environmental chambers & Real Time aging room.
Planning, Communication and Design Control: Follow all GMPs. Communicate work priorities and job status regularly to all interested parties. Maintain work tickets. Estimate time necessary for specific design documentation changes and prototype construction activity.
Two-year technical degree in Electronic Engineering Technology.
5+ years of electrical technician experience within a structured product prototyping environment, including at least two years in a GMP-enforced environment.
Experience with operating lab equipment such as oscilloscopes, meters, environmental chambers, force testers, etc. Ability to build prototype circuits, cables and test fixtures.
Experience with OrCAD schematic capture, LabVIEW & change management systems. Working knowledge of Solid Works or other 3D CAD package.