100% ONSITE Pleasanton, CA
Pay : $75-$82 / hr
REQUIRED :
- MUST HAVE Electrical Engineering Degree and 8 years of exp with Test Engineering, PCBA design and testing experience
- knowledge (transistors, dryers, schematics) – V&V experience – (PCB, transistors, schematics, etc…)
- Must have knowledge multiple aspects of electrical testing and electrical design
Ability to design a test fixture
Writing test protocolsRegulated industryIEC 60601Lab ViewPrefer
Creation and running of test cases on medical devicesAbility to design an automated text fixtureFPGA experienceFMEA MethodologyClass II and III medical devicesISO 13485Altium DesignDesign Input / Design OutputAcoustic electrical EngineeringJob Description :
The Electrical Test Engineer will be responsible for performing and documenting verification and integration activities of complex electro-mechanical medical devices with software. It includes testing of specified components and overall product functionality to ensure product safety and efficacy. The engineer is experienced in all aspects of product development life cycle with understanding of systems engineering processes in Medical Device industry. The Electrical Test Engineer will work with a multi-disciplinary engineering teams including system, software, electrical, and mechanical design engineers, and other functions to ensure the highest quality for class II medical devices.
Main Areas of Responsibilities :
Perform the Electronics Design and EMC pre-test activities for complex electro-mechanical medical device products within the Product Development teamIdentify electrical tests, prepare electrical test environment and ensure test preconditions are met prior to formal testing activitiesVerify (including TEC / low voltage power control / AC voltage and current / PCB / FPGA / analog electrical components tests) that Analog and Digital electrical design that electrical system, sub-systems and appropriate supporting documentation meet detailed design as well as related requirement specifications, while ensuring that related standards are appliedVerify (including EMC / EMI / ESD / Radio tests) that system with related electrical design and appropriate supporting documentation meets all safety, regulatory and industry compliance standards, and codes while ensuring that related standards are appliedHelp build Electrical Test Lab, and support testing of Electronics Design and EMC Testing in the Test Lab; follow Laboratory Best Practices and safety protocolsDevelop and maintain verification protocols, verification reports, requirements documents, and other related technical documentation while ensuring related international standards are appliedVerify translation of Design Inputs into test design and test protocols, and support creation of system architecture and detailed design documentationContribute to risk analysis activities for the product development including hazards analysis, Design FMEA, and Use FMEASafely work with hazardous systems containing high / low voltage, high / low temperatures, high acoustic, and high pressureSupport review and approval of design and process changes as well as deviations related to new and existing medical device productsCommunicate and collaborate with a wide range of project contributors and stakeholders spanning the organization, and external partners including technical leaders for product design, development, integration, testing, and reliability improvements