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Electrical Engineer

Company: BiVACOR Inc
Location: Huntington Beach
Posted on: August 3, 2022

Job Description:

BiVACOR Inc. is looking for an Electrical Engineer (EE) to join our international team for immediate start.To be considered for this role, you MUST:- at least 3 years experience in component, integration, and system tests of class II/III medical devices; AND- practical implementation of electrical engineering principles for medical devices.The Electrical Engineer (EE) will be an integral member of the BiVACOR engineering team, support design and analysis, verification and validation efforts of the BiVACOR implantable artificial heart, with a focus on the external patient controller subsystem. The EE will utilize technical ability to assist in developing system specifications, test methods and perform component, integration, and system tests of the BiVACOR device. With a clear technical vision, the EE is required to support the development of all electrical systems for the BiVACOR implantable artificial heart. This role will work closely with the electrical engineering team and support prototyping concepts, providing models, participating in design reviews, and assembly of components for testing purposes. This role reports to the senior electrical engineer and will require to interact with external vendors and consultants.RESPONSIBILITIES- Support the engineering design, analysis and verification of medical devices including researching components, simulations, schematic capture, component placement and routing on printed circuit boards (PCB), building prototypes, analyzing and verifying designs, and successfully transitioning to manufacture.- Support development and manufacturing of all hardware subsystems including: Controller; Backup and External Batteries and Cables; External Battery Charger; DC Power Supply- Participate in design tasks including component selections, schematic reviews, PCB layout reviews, hardware testing, evaluation and optimization activities.- Review electrical designs for compliance with electrical safety, EMC/EMI standards and applicable medical device standards.- Debug electronic systems, electrical circuit problems and identify corrective actions.- Participate in electrical design failure mode effect analyses and hazard analyses.- Provide support for the manufacture of prototype Controllers and associated accessories

  • Develop and support preparation of work instructions and test procedures required to build controllers
  • Review manufacturing and design issues, identify root causes and determine corrective action- Own the design and specification of system subcomponents in the external controller electronics and peripheral components- Design and development of efficient test procedures for design verification and stress testing according to defined specifications.
    • Participate in the analysis of product and software design input specifications and design test strategies, test procedures and test cases to verify the performance of components and systems
    • Support the development of special tooling or fixturing to perform testing.
    • Define and justify test sample size(s), test conditions, and test apparatus.
    • Review test protocols and reports from third-party testing facilities.
    • Contribute to work instruction documentation which describe the testing procedures.- Conduct and report on experiments for verification and validation of the product input specifications.
      • Manage and ensure appropriate certifications for test equipment.
      • Verify test coverage and consistency of devised testing procedures.- Create documentation (specifications, design documents, protocols, procedures, work instructions) adhering to quality procedures, regulations, standards, and industry best practices under Design Control for regulatory submissions to the FDA.REQUIREMENTS- Bachelor's Degree in Electrical Engineering or equivalent.- Experienced in component, integration, and system tests of class II/III medical devices - minimum 3 years.- Practical implementation of electrical engineering principles for medical devices.- Experience with digital and analog electronic device development.- Working knowledge of electromagnetic physics and analysis, EMC requirements and test methods.- Understanding and application of applicable standards and FDA requirements (IEC 60601, ISO 14971, IEC 62304, ISO 13485).- Advanced use of electronic equipment such as spectrum analyzers, oscilloscopes and multi-meters.- Experience working with external suppliers and contract manufacturers for PCB fabrication and assembly.- Some travel required domestically.

Keywords: BiVACOR Inc, Huntington Beach , Electrical Engineer, Engineering , Huntington Beach, California

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