• Sr. Electrical Test Engineer

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    Job #2314065746

  • The Senior Electrical Test Engineer will be responsible for planning, performing and documenting system 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 strong understanding of systems engineering processes in a regulated industry. The Senior Electrical Test Engineer will work with a multi-disciplinary engineering teams including system, software, electrical, and mechanical design engineers, and other functions to ensure highest quality for class II medical devices. We are looking for a motivated self-starter who is energetic, has a 'make it happen in a compliant way' attitude and can thrive in a fast-paced environment.

    Responsibilities:

    • Lead and perform the EMC and electrical test activities for complex electro-mechanical medical device products within the Product Development team

    • Build Electrical Test Lab, and provide test engineering direction and oversight of testing of EMC Testing in the Test Lab; follow Laboratory Best Practices and safety protocols

    • Translate Design Inputs into test design and test protocols, and support creation of system architecture and detailed design documentation

    • Develop and maintain system verification and integration planning document, verification protocols, verification reports, requirements documents, and other related technical documentation while ensuring related international standards are applied

    • Contribute to risk analysis activities for the product development including hazards analysis, Design FMEA, and Use FMEA

    • Identify and perform appropriate electrical tests to ensure continued compliance

    • Prepare electrical test environment and ensure test preconditions are met prior to formal testing activities

    • Verify, including EMC / EMI / ESD / Radio tests, that system and electrical design and appropriate supporting documentation meets all safety, regulatory and industry compliance standards, and codes while ensuring that related (including IEC 60601, EN 300 328 and EN 300 330 ) standards are applied

    • Safely work with hazardous systems containing high 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 product

    • 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

    • Master of Engineering or related technical field

    • 10+ years of experience in regulated industry testing complex electro-mechanical systems

    • Strong understanding of 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, and ISO 14971

    • Firm technical background of medical device testing including Temperature monitoring and control, TEC's control, Low voltage power control, Mains AC voltage, Analog component building blocks (ADC, DAC, OP-AMP, FET, transistor, resistor, capacitor, inductor, etc.)

    • Good knowledge of engineering tools including spectrum analyzers, logic analyzers, network analyzers, oscilloscopes, RF communication analyzers, DVMs, Smith charts, etc.

    • Proficient in using Requirement Management and Traceability tools

    • Hands-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 standards

    • Basic engineering laboratory skills: weights and measures, chemical hygiene, materials safety planning, personal protective equipment, contamination control, job hazard analysis, and work instruction

    • An enthusiastic team builder and player

    • Excellent communication, written and personal computer skills

    • Ability to earn trust, maintain positive and professional relationships, and strengthen our culture of inclusion