System Test Engineer I

ENCHANNEL MEDICAL LTD

System Test Engineer I

Irvine, CA
Full Time
Paid
  • Responsibilities

    Position Title: System Test Engineer I

    **Department: R &D, **System Engineering

    Reports to: Director, System Engineering

    At Enchannel Medical, we’re 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 heart rhythm patients, our discerning technology, paired with our passion for innovation, leads to enduring outcomes.

    Position Overview

    We are seeking a System Test Engineer I to support R&D of complex medical system and perform system performance V&V. This test engineer will be responsible for creating and executing system V&V test protocols, and support IEC safety tests at 3rd party test house. This role will also provide input and support for the system R&D.

    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.

    • Develop and build system prototypes for system performance evaluation.

    • Design and execute test methods and identify any defects or issues that could impact the user experience or system performance.

    • Ensure compliance with quality system procedures and regulatory standards.

    • Performs troubleshooting on system components and subassemblies with the purpose of finding solutions and documenting the changes.

    • Design and execute V&V protocols and Work Instructions and document the results properly.

    • Release system test report documents in the QMS system following the required process.

    • Perform or support IEC safety test at 3rd party test house like Intertek.

    • Perform PCB rework and soldering under a microscope as needed.

    • Creates system testing tools and parts as needed.

    • Ensures that the tools and testing equipment are following the IQ/OQ process.

    Experience, Education 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.

    • 0-3 years of related technical experience and a BS degree.
    • Experience in regulated medical devices industries (IEC 60601) is preferred.
    • Experience performing soldering of small components on PCB under a microscope is required.
    • Experience running MATLAB or Python applications/scripts for data collection and analysis is preferred.
    • Demonstrated knowledge of medical device V&V principles and practices, and procedures.
    • Must have verbal and written communication skills with the ability to produce reports/information, as required and thoroughly share information with others.
    • Experience of Operating basic Electrical lab equipment, e.g., Oscilloscope and signal generator is required.

    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.