Electrical Engineer, Design and Quality

NuevoSono, a T45 Labs portfolio company, is seeking a Quality Engineer with expertise in Electrical Engineering to support product development, manufacturing, and quality assurance for medical devices incorporating electrical and embedded systems. This role will focus on hands-on testing, process validation, and documentation development for electrical components, PCBs, and system integrations. The ideal candidate has a strong foundation in electrical design verification, test method development, and risk assessment for medical electronics.

Responsibilities

Testing and Electrical Quality Assurance

• Execute hands-on testing for electrical components, PCB assemblies, power systems, and embedded electronics.
• Develop and validate test methods and protocols for electrical and system-level verification.
• Perform functional testing, reliability testing, and failure analysis for electrical subsystems.
• Design and implement automated and manual test setups to streamline quality control.

Process Development and Manufacturing Support

• Identify gaps in electrical manufacturing and testing processes, proposing and implementing improvements.
• Create and optimize workflows for electrical system manufacturing and validation.
• Develop fixtures and test setups to support electrical system validation and integration.
• Ensure compliance with IEC 60601, FDA regulations, ISO 13485, and other applicable standards.

Documentation and Risk Management

• Develop and maintain Manufacturing Process Instructions (MPIs), work instructions, test methods, protocols for DV, and reports for electrical and system-level quality.
• Conduct risk assessments, including FMEA and hazard analysis, for electrical and system components (ISO 14971).
• Work with R&D, regulatory, and manufacturing teams to ensure electrical designs meet quality and compliance requirements.

Qualifications

• Bachelor’s degree in Electrical Engineering, Biomedical Engineering, or a related field.

• 5+ years of experience in quality engineering, electrical testing, or hardware validation for medical devices or regulated industries.
• Hands-on experience with oscilloscopes, multimeters, power analyzers, and other electrical testing tools.
• Experience with PCB testing, electrical system validation, and embedded hardware troubleshooting.
• Strong knowledge of IEC 60601, ISO 13485, FDA regulations, and risk management (ISO 14971).
• Familiarity with automated testing, scripting for test automation, and lab equipment integration is a plus.

Location and Compensation

This is an onsite position, based in our Santa Clara, CA office.

T45 Labs is committed to fair and equitable pay practices, and compensation may include bonuses, equity, and benefits as part of the total rewards package.

The anticipated salary range for this position is $136,000 - $184,000 annually, based on San Francisco Bay Area market data. Actual compensation will vary depending on factors such as experience, and skills.

Equal Employment Opportunity Statement

T45 Labs and its affiliated companies are Equal Opportunity Employers. We celebrate diversity and are committed to creating an inclusive environment for all employees. Employment decisions are based on qualifications, merit, and business needs.

We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected status.