Medical Device Electrical Test Engineer

Position Title: Electrical Test EngineerLength of Contract: 12 months (extension possible)Location/Site: Onsite , Pleasanton, CAWhat are the top 3-5 skills, experience or education required for this position:Medical Device Electrical Engineering / TestingPCBA designIEC 60601 knowledgeFPGA experienceLabView experienceAre you open to look at candidates willing to relocate? YesYears of experience/education and/or certifications required: 8What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification? Experience with acoustic systemsWork Schedule (Define days,# of hours)/ Is Overtime offered or required? Mon-Fri / 8 hours / overtime only if requestedDoes this position offer the ability to work remotely on a regular basis? NoPosition OverviewThe 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 improvementsQualifications:Bachelor’s or master’s degree in engineering or related technical field8 years of experience in regulated industry testing complex electro-mechanical systemsUnderstanding Design Controls for medical device development including experience with medical device product life-cycle processes conforming to standards including ISO 9000, ISO 13485, IEC 60601, IEC 62304, EN 300 328, EN 300 330, and ISO 14971Technical background of medical device testing including Temperature monitoring and control, TEC’s control, Low voltage power control, Mains AC voltage, PCBA, FPGA, Analog component building blocks (ADC, DAC, OP-AMP, FET, transistor, resistor, capacitor, inductor, etc.), USB, RS-xxx, SPI, Microwire, I2C, SATA, PCIEKnowledge of engineering tools including spectrum analyzers, logic analyzers, network analyzers, oscilloscopes, RF communication analyzers, DVMs, Smith charts, etc.Proficient in using Requirement Management, Traceability, Electrical simulation, Electrical design and Microsoft Office toolsHands-on experience with developing design verification protocols, execution, and report generation as well as with conducting electrical verification of high and low temperature, high acoustic, and high liquid pressure systems including EMC, EMI, ESD, and radio standardsBasic engineering laboratory skills: weights and measures, chemical hygiene, materials safety planning, personal protective equipment, contamination control, job hazard analysis, and work instructionAn enthusiastic team builder and playerExcellent communication, written and personal computer skillsAbility to earn trust, maintain positive and professional relationships, and strengthen our culture of inclusionCompany DescriptionRangam Consultants is an award winning company from the staffing fraternity. We are a multiple service provider in the Information Technology, Scientific, Engineering and administrative fields. We have a proven track record for successfully delivering mission critical consulting, support and recruiting services to various government and Fortune 500 clients.

Salary : $70 - $76