Hardware Engineer, Staff (Test)

Enchannel Medical • Irvine, CA

2d

About The Position

Enchannel Medical is redefining the boundaries of electrophysiology with our next-generation DePolar™ mapping system and integrated NanoAblate™ PFA platform. Driven by our global mission to enhance the quality-of-life of cardiac arrhythmia patients, our discerning technology, paired with our passion for innovation, leads to enduring outcomes. The Hardware Engineer, Staff (Test) is responsible for the design, validation, and system integration of complex hardware subsystems for electrophysiology (EP) platforms, including mapping and ablation systems. This role ensures hardware performance, signal fidelity, and patient safety while driving verification strategies and regulatory compliance.

Requirements

• Strong experience with Design for Testability (DFT) and Design for Manufacturability (DFM)
• Bachelor’s degree in Electrical Engineering or Biomedical Engineering with 8+ years of experience, or Master’s degree with 6+ years, or PhD with 3+ years experience.
• Experience in medical device development highly desired.

Responsibilities

• Design and development of automated board-level and system-level hardware test fixtures (functional test, bed-of-nails, HIL systems) for complex PCBAs
• Perform validation (IQ, OQ, PQ) of test hardware, test software, and test methodologies.
• Be the voice for Manufacturing in the design phase to ensure the final hardware design is testable.
• Ability to define test architectures for high-channel-count acquisition systems for electrophysiology and pulse-field ablation systems.
• Participate in the design and development of complex analog front-end, data acquisition, and isolation circuits for patient-connected medical systems.
• Support hardware architecture definition and lead cross-functional tradeoff analysis across performance, safety, manufacturability, and cost.
• During the verification and validation phase, execute comprehensive hardware V&V strategies, including test protocol development, test execution, and reporting.
• Lead root cause analysis and resolution of hardware- and system-level issues using structured methodologies, supporting CAPA and continuous improvement.
• Ensure compliance with regulatory and safety standards, including IEC 60601-1 and IEC 60601-1-2, and support regulatory submissions and audits.
• Drive development of Design History File (DHF) deliverables and contribute to risk management activities (ISO 14971), ensuring full traceability.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior