Engineer III

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) What are the top 3-5 skills, experience or education required for this position: 1. Medical Device Electrical Engineering / Testing 2. PCBA design 3.

IEC 60601

knowledge 4. FPGA experience 5. LabView experience Open to candidates willing to relocate? Yes Years of experience/education and/or certifications required: 8 Nice to have (but not required): Experience with acoustic systems

Position Overview:

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 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 that electrical system, sub-systems and appropriate supporting documentation meet detailed design as well as related requirement specifications, while ensuring that related standards are applied
• Verify (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 applied

• 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 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 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 component building blocks (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 communication analyzers, DVMs, Smith charts, etc.
• Proficient in using Requirement 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 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
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