Hardware Engineer, Staff (Test)

EnChannel Medical LTD; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

EnChannel Medical LTD is seeking a Staff Hardware Engineer (Test) to design, validate, and integrate complex hardware subsystems for EP platforms, ensuring signal fidelity and patient safety. You will lead test architecture and automation in a fast-paced development environment.

The role requires strong experience in hardware testability and regulatory compliance, with a focus on high-channel-count acquisition systems and isolation circuits for medical devices.

Qualifications

• Bachelor’s or higher in electrical/biomedical engineering with extensive hardware experience.
• Medical device development experience highly desired.
• Strong verification, validation and regulatory know-how.

Responsibilities

• Design and validate hardware test fixtures for PCBAs and systems.
• Lead V&V strategies, test protocols, and reporting.
• Ensure IEC 60601-1 and related standards compliance.
• Drive cross-functional tradeoffs in performance, safety, and manufacturability.

Skills

Design for Testability

Design for Manufacturability

Hardware verification

Root cause analysis

Regulatory compliance

Education

Bachelor’s degree in Electrical Engineering or Biomedical Engineering

Master’s degree

PhD (relevant field)

Tools

HIL systems

Bed-of-nails fixtures

Test software

Job description

Position Title: Hardware Engineer, Staff (Test)

Department: R&D - Hardware Engineering

Reports to: Director, Hardware Engineering

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.

Position Overview

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.

Duties And Responsibilities

The following are the major responsibilities needed for the role. Additional responsibilities, tasks, and duties will be assigned and required as needed.

• 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.


• Strong experience with Design for Testability (DFT) and Design for Manufacturability (DFM)


• Be for voice for Manufacturing in design phase to ensure final hardware design is testable.


• Ability to define test architectures for high-channel-count acquisition system for electrophysiology and pulse-field ablation system


• 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 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.

Education, Experience And Skills Required

Below are the minimum skills, formal education, certifications or training, and practical experience required to perform the general functions and duties of the role.

• 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.

Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum new hire pay for the position located in California. Within the range, individual pay is determined by location, additional factors, including job-related skills, experience, and relevant education or training.

EnChannel Medical is an E-Verify and equal opportunity employer. We believe in hiring a diverse workforce and sustaining an inclusive, people-first culture. We are committed to non-discrimination on any protected basis, such as disability and veteran status, or any basis covered under acceptable law.

Only qualified candidates will be contacted.

JOB CODE: 1387