Synectics Inc.
Overview
The Electrical Test Engineer will be responsible for performing and documenting verification and integration activities of complex electro-mechanical medical devices with software, including testing of specified components and overall product functionality to ensure product safety and efficacy. The engineer is experienced in all aspects of the product development life cycle with understanding of systems engineering processes in the Medical Device industry. Responsibilities
Work with 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. 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 that analog and digital electrical design, system, sub-systems and relevant documentation meet detailed design and requirement specifications, while ensuring that related standards are applied (TEC / low voltage power control / AC voltage and current / PCB / FPGA / analog components). Verify 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 applied (EMC / EMI / ESD / Radio tests). Help build 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 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. 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 of Design Controls for medical device development including experience with ISO 9000, ISO 13485, IEC 60601, IEC 62304, EN 300 328, EN 300 330, ISO 14971 Technical background of medical device testing including Temperature monitoring and control, TEC\'s control, Low voltage power control, Mains AC voltage, PCBA, FPGA, Analog components (ADC, DAC, OP-AMP, FET, transistor, resistor, capacitor, inductor, etc.), USB, RS-xx, 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 conducting electrical verification of high/low temperature, high acoustic, and high liquid pressure systems including EMC, EMI, ESD, and radio standards Basic engineering laboratory skills and safety practices Excellent communication, written and interpersonal skills Ability to earn trust and contribute to an inclusive culture LabVIEW experience Experience with acoustic systems Benefits and notices
California Fair Chance Act: Synectics will consider qualified applicants with a criminal history pursuant to the California Fair Chance Act. You do not need to disclose your criminal history or participate in a background check until a conditional job offer is made to you. After a conditional offer and background check, you will be able to explain circumstances or challenge accuracy of the report. More information at calcivilrights.ca.gov/fair-chance-act/. Healthcare Insurance through BlueCross BlueShield of Illinois; eligibility after 60 days; premiums subsidized. Dental Insurance through MetLife; eligibility after 60 days. Vision Insurance through VSP; eligibility after 60 days. 401(k) Plan with annual enrollment dates Jan 1, Apr 1, Jul 1, Oct 1. Technical Certification Bonus: up to $500 for approved professional certification after successful completion and documentation. Synectics is an equal opportunity employer.
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The Electrical Test Engineer will be responsible for performing and documenting verification and integration activities of complex electro-mechanical medical devices with software, including testing of specified components and overall product functionality to ensure product safety and efficacy. The engineer is experienced in all aspects of the product development life cycle with understanding of systems engineering processes in the Medical Device industry. Responsibilities
Work with 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. 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 that analog and digital electrical design, system, sub-systems and relevant documentation meet detailed design and requirement specifications, while ensuring that related standards are applied (TEC / low voltage power control / AC voltage and current / PCB / FPGA / analog components). Verify 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 applied (EMC / EMI / ESD / Radio tests). Help build 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 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. 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 of Design Controls for medical device development including experience with ISO 9000, ISO 13485, IEC 60601, IEC 62304, EN 300 328, EN 300 330, ISO 14971 Technical background of medical device testing including Temperature monitoring and control, TEC\'s control, Low voltage power control, Mains AC voltage, PCBA, FPGA, Analog components (ADC, DAC, OP-AMP, FET, transistor, resistor, capacitor, inductor, etc.), USB, RS-xx, 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 conducting electrical verification of high/low temperature, high acoustic, and high liquid pressure systems including EMC, EMI, ESD, and radio standards Basic engineering laboratory skills and safety practices Excellent communication, written and interpersonal skills Ability to earn trust and contribute to an inclusive culture LabVIEW experience Experience with acoustic systems Benefits and notices
California Fair Chance Act: Synectics will consider qualified applicants with a criminal history pursuant to the California Fair Chance Act. You do not need to disclose your criminal history or participate in a background check until a conditional job offer is made to you. After a conditional offer and background check, you will be able to explain circumstances or challenge accuracy of the report. More information at calcivilrights.ca.gov/fair-chance-act/. Healthcare Insurance through BlueCross BlueShield of Illinois; eligibility after 60 days; premiums subsidized. Dental Insurance through MetLife; eligibility after 60 days. Vision Insurance through VSP; eligibility after 60 days. 401(k) Plan with annual enrollment dates Jan 1, Apr 1, Jul 1, Oct 1. Technical Certification Bonus: up to $500 for approved professional certification after successful completion and documentation. Synectics is an equal opportunity employer.
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