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Senior Electrical Engineer

Company: BiVACOR
Location: Cerritos
Posted on: May 3, 2021

Job Description:

BiVACOR is seeking a highly experienced Senior Electrical Engineer (EE) to join our international team. The senior EE will support the BiVACOR electrical and electronic efforts to design, develop and test all electrical systems for the BiVACOR implantable artificial heart. With a clear technical vision, the senior EE is required to support the development of all electrical systems for the BiVACOR implantable artificial heart.This role will guide the BiVACOR engineering team in best electrical and electronic development and testing practices and inject quality into the development cycle through the design verification and validation phase. This roll requires the management of both the in-house development effort and the interaction with external vendors and consultants.For the location in Cerritos (CA), BiVACOR is looking for motivated and flexible team members, who are keen to contribute to this active and dynamic project. Strong organizational, time management, and technical skills paired with an analytical and problem-solving thinking in a deadline driven environment is needed. This role requires the ability to work with minimal supervision and offers the opportunity to mentor junior electrical engineers and technicians.This role requires creativity and flexibility to find the best solution in a multidiscipline and dynamic research and development environment. RESPONSIBILITIES- Support the engineering design, analysis and verification of medical devices.- Support development and manufacturing of all electrical subsystems including o Motoro Magnetic bearingo Percutaneous leado Controller- Prepare and independently review electrical and electronic designs, schematics, PCBA layouts and bills of materials.- Identify test methods, and development of test fixtures for purpose of design verification test cases.- Apply principles and techniques of electrical engineering to analyze failures to improve design and manufacturing processes.- Debug electrical circuit problems and implement corrective action. Document and release the corrective action.- Ensure electrical design complies with medical safety, EMC/EMI standards and applicable Class III medical standards.- 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.- Lead, mentor, and support the electrical and mechanical engineers in the development of medical electrical systems and devices.- Provide schedule estimations for electrical engineering activities and resourcing needs.- Undertake electrical design, failure mode effect analyses and hazard analyses- Utilize recognized engineering theory and analysis techniques to define technical problems as well as investigate and provide guidance for solutions.- Assist in the identification and management of external design services, vendors and consultants.- Lead risk analysis and fault analysis process for the electrical systems.- Ensure compliance of all electrical systems to relevant standards and regulatory requirements.- Work within the organization to optimize interaction and facilitate system level solutions.- Participate in development planning and resource management activities as required.EXPERIENCE- Advanced practical implementation of electrical engineering principles for medical devices.- Strong experience in designing electrical circuits for medical devices.- Advanced experience with digital and analog electronic device development, including:o FPGA products and HDL languageso digital and analog circuit designo wired and wireless communication protocols (SPI, I2C, Bluetooth Low Energy, WiFi, etc),o low voltage circuit design and PCB layout techniques,o motor control o rotary pumps and their functional principles ,o wireless energy transfer and rechargeable batteries,o design and characterization of implantable electronics,o microprocessor-based designs for embedded applications.- Advanced working knowledge of electromagnetic physics and analysis, EMC requirements and test methods.- Detail understanding and application of FDA requirements, IEC 60601, ISO 14971, IEC 62304, ISO 13485 and medical quality management systems for medical device development and verification.- Advanced design and review skills of printed circuit boards (PCB) layouts, electrical schematics/drawings and bill of materials. - Sign-off of formal electrical engineering documentation (schematics, PCB fabrication drawings, PCB assembly drawings, etc.).- Experience working with vendors and contract manufacturers for PCB fabrication and assembly.- Advanced knowledge and practical experience in conducting failure mode effect analysis s and hazard analyses.- Detailed understanding of control theory, embedded firmware (C, C++, etc.), VHDL/Verilog.- Advanced use of electronic equipment such as spectrum analyzers, oscilloscopes and multi-meters.- Advanced technical report writing skills to support submissions to FDA.REQUIREMENTS- Bachelor s Degree in Electrical Engineering, Electronic Engineering, Mechatronic Engineering or Biomedical Engineering.- 10+ years industry experience in the development and testing of class III medical devices.- In-depth understanding of applicable standards, particular IEC 60601, ISO 14971. Associated topics: artificial intelligence, electronic engineering, informatic, linux, malware, python, radar, robotics, software, software engineer

Keywords: BiVACOR, Cerritos , Senior Electrical Engineer, Other , Cerritos, California

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