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).

• 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

• 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