Engineer III

Overview Position Title: Electrical Test Engineer. Length of Contract: 12 months (extension possible). Location/Site: Pleasanton, CA 94588 (Onsite - Mon-Fri / 8 hours / overtime only if requested). Responsibilities Perform the Electronics Design and EMC pre-test activities for complex electro-mechanical medical device products within the Product Development team Identify electrical tests, prepare electrical test environment and ensure test preconditions are met prior to formal testing activities Verify (including TEC / low voltage power control / AC voltage and current / PCB / FPGA / analog electrical components tests) that Analog and Digital electrical design of the system, sub-systems and appropriate supporting documentation meet detailed design requirements and related specifications while ensuring applicable standards are followed Verify (including EMC / EMI / ESD / Radio tests) that the system with related electrical design and supporting documentation meets safety, regulatory and industry compliance standards and codes Help build the Electrical Test Lab, and support testing of Electronics Design and EMC Testing in the Test Lab; follow Laboratory Best Practices and safety protocols Develop and maintain verification protocols, verification reports, requirements documents, and other related technical documentation while ensuring related international standards are applied Verify translation of Design Inputs into test design and test protocols, and support creation of system architecture and detailed design documentation Contribute to risk analysis activities for the product development including hazards analysis, Design FMEA, and Use FMEA Safely work with hazardous systems containing high/low voltage, high/low temperatures, high acoustic, and high pressure Support review and approval of design and process changes as well as deviations related to new and existing medical device products Communicate and collaborate with project contributors and stakeholders spanning the organization and external partners, including technical leaders for product design, development, integration, testing, and reliability improvements Qualifications Bachelor's or master's degree in engineering or related technical field 8+ years of experience in regulated industry testing complex electro-mechanical systems Understanding Design Controls for medical device development including standards such as ISO 9000, ISO 13485, IEC 60601, IEC 62304, EN 300 328, EN 300 330, and ISO 14971 Technical background in medical device testing including Temperature monitoring and control, TEC control, Low voltage power control, Mains AC voltage, PCBA, FPGA, Analog components (ADC, DAC, OP-AMP, FET, transistor, resistor, capacitor, inductor, etc.), USB, RS-xxx, SPI, Microwire, I2C, SATA, PCIE Knowledge of engineering tools including spectrum analyzers, logic analyzers, network analyzers, oscilloscopes, RF analyzers, DVMs, Smith charts Proficient in using requirements management, traceability, electrical simulation, electrical design and Microsoft Office tools Hands-on experience with developing design verification protocols, execution, and report generation as well as with electrical verification of high/low temperature, high acoustic, and high liquid pressure systems including EMC, EMI, ESD, and radio standards Basic engineering laboratory skills: weights and measures, chemical hygiene, materials safety planning, PPE, contamination control, job hazard analysis, and work instruction Team-oriented with strong collaboration skills Excellent communication, written and computer skills Ability to earn trust, maintain positive and professional relationships, and strengthen our culture of inclusion #J-18808-Ljbffr