Hardware Engineer, Staff (Test)

Hardware Engineer, Staff (Test)

ENCHANNEL MEDICAL LTD

Irvine, CA Job Details $114,177 - $150,000 a year 15 hours ago Qualifications Quality control corrective actions Biomedical engineering experience within healthcare Analog circuit design Engineering testing Bachelor's degree in electrical engineering ISO standards Engineering Bachelor's degree in biomedical engineering Compliance audits & assessments Biomedical Engineering Corrective and preventive actions (CAPA) Electrical engineering Electronics design Electrophysiology 3 years Patient safety Master's degree Continuous improvement Doctor of Philosophy Scientific protocols Developing automated testing protocols Design for manufacturability (DFM) Regulatory submissions Manufacturing Root cause analysis Senior level Electrical Engineering Cross-functional collaboration Research & development Regulatory compliance management

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Hardware Engineer, Staff (Test)

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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.