Lead Electrical Test Engineer

Echo Neurotechnologies•San Francisco, CA

14h

About The Position

As the Lead Electrical Test Engineer, you will be responsible for planning, coordinating, and executing system-level electronics testing that demonstrates Echo’s BCI devices are safe, effective, and compliant with FDA and international standards. You will lead electrical testing across Pre-V&V, V&V, and production, ensuring requirements are testable, designing rigorous test protocols, and delivering FDA-ready evidence for design controls. In addition to verification and validation, you will establish and maintain production test strategies to ensure reliable device manufacturing. With your expertise in electronic systems and test engineering, you will bridge development and operations to ensure Echo’s implantable and wearable systems meet the highest safety, quality, and manufacturability standards.

Requirements

Bachelor’s or Master’s degree in Electrical Engineering, Computer Engineering, Biomedical Engineering, or related field.
7+ years of experience in electronics/system testing, verification, and validation for medical devices.
Proven experience leading component-level, subsystem, and system-level test campaigns for Class II or III medical devices (implantable preferred).
Experience in designing and scaling production test systems for medical electronics.
Strong knowledge of standards and regulations: 21 CFR Part 820 (Design Controls) IEC 60601 (Electrical Safety & EMC) ISO 14971 (Risk Management) IEC 62366 (Usability Engineering)
Familiarity with hardware-in-loop and system integration test methods.
Experience collaborating across disciplines (EE, FW, ME, QA, RA, Manufacturing, external labs).
Expertise in electronic system test methods: signal integrity, power analysis, EMI/EMC, environmental stress, and safety compliance.
Ability to design, implement, and oversee system-level verification and validation test plans.
Proven experience developing and maintaining production test setups, fixtures, and automation for medical device manufacturing.
Proficiency with lab equipment: oscilloscopes, spectrum analyzers, DMMs, logic analyzers, power analyzers.
Skilled in writing clear, defensible test protocols and reports for regulatory and manufacturing use.
Strong organizational discipline in traceability, version control, and change management.
Ability to lead cross-functional test campaigns and manage external test labs/CROs.
Excellent communication skills, able to translate test results for engineers, QA/RA, and regulatory reviewers.

Responsibilities

Define and lead system-level test strategies across electrical subsystems, integrated device, and system validation.
Translate system and design requirements into test protocols with clear, measurable acceptance criteria.
Lead Pre-V&V electronics efforts: bench bring-up, early feasibility testing, and design-for-testability.
Direct system-level verification and validation testing (bench, hardware-in-loop, simulated clinical use, IEC 60601 electrical safety).
Develop and maintain production test systems: design test fixtures, sockets, automation scripts, and scalable processes for manufacturing.
Collaborate with Electrical, Firmware, Systems, QA, and Regulatory teams to ensure compliance with FDA 21 CFR Part 820, ISO 14971 (risk management), and related standards.
Liase with System DVT lead, internal teams, and consultants.
Generate Verification and Validation Reports, production test documentation, and FDA submission-ready documentation.
Lead failure investigations at system and production level, ensuring root cause analysis and corrective actions are documented and retested.
Provide test engineering leadership in support of design transfer to manufacturing and ongoing production quality.