What are the responsibilities and job description for the Electrical Test Engineer-Medical Device position at Collabera?
Job Summary:
The Electrical Test Engineer will perform and document verification and integration activities for complex electro-mechanical medical devices with software. This role ensures product safety, efficacy, and regulatory compliance through comprehensive electrical testing, lab setup, and collaboration with multi-disciplinary engineering teams.
Key Responsibilities:
• Perform electronics design and EMC pre-test activities for complex electro-mechanical medical devices.
• Identify electrical tests, prepare test environments, and ensure preconditions are met prior to formal testing.
• Verify analog and digital electrical systems, components, and PCBA/FPGA designs against specifications and applicable standards.
• Conduct EMC, EMI, ESD, and radio compliance tests to ensure adherence to safety and regulatory standards.
• Build and support Electrical Test Lab activities, following laboratory best practices and safety protocols.
• Develop and maintain verification protocols, reports, requirements documents, and other technical documentation.
• Contribute to risk analysis activities including hazard analysis, Design FMEA, and Use FMEA.
• Review and approve design and process changes and deviations for new and existing medical devices.
• Collaborate with internal and external stakeholders to ensure high-quality design, integration, and testing outcomes.
Required Qualifications:
• Bachelor’s or Master’s degree in Electrical Engineering or a related technical field.
• 8 years of experience testing complex electro-mechanical systems in a regulated industry.
• Understanding of medical device design controls and product lifecycle processes, including ISO 9000, ISO 13485, IEC 60601, IEC 62304, EN 300 328, EN 300 330, and ISO 14971.
• Hands-on experience with PCBA, FPGA, analog components (ADC, DAC, OP-AMP, FET, transistor, resistor, capacitor, inductor), and electrical systems including TEC, AC voltage/current, USB, RS-xxx, SPI, I2C, SATA, and PCIe.
• Proficiency with electrical lab tools: spectrum analyzers, logic analyzers, oscilloscopes, RF analyzers, network analyzers, and DVMs.
• Experience developing and executing design verification protocols and generating test reports.
• Proficiency in requirement management, traceability, electrical simulation, electrical design, and Microsoft Office.
• Basic engineering laboratory skills including chemical hygiene, materials safety, PPE usage, contamination control, and hazard analysis.
• Strong teamwork, communication, and interpersonal skills.
Preferred Qualifications:
• Experience with acoustic systems testing.
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.
Pay Range: $60/hr to $70/hr
Salary : $60 - $70
