Senior Electrical Engineer
2375 Morse Ave Irvine, CA 92614 US
As Senior R&D Electrical Engineer, you will be part of our Electrophysiology catheter and capital equipment product development team focused on delivering the future in diagnostic, imaging, and ablation therapy catheters. This role will involve a range of responsibilities including but not limited to design development and maturation, requirement development, testing and data analysis, test method development and validation, and contract manufacturer development and support. You will be expected to lead and contribute to innovation and product development projects for ultrasound imaging (systems and catheter) from design concepts, product development and pre-clinical assessments to product launch.
Duties and Responsibilities:
- Contribute to systems-level product development, design specifications and verifications that complies with related medical device regulations/standards (FDA, IEC, etc.) and internal quality management and design control processes.
- Establish components and product requirements and specifications.
- Apply advanced engineering and scientific principles to the evaluation and solution of technical problems.
- Perform the layout, construction, and evaluation of a variety of prototype printed circuit boards, fixtures, and tools required for development and testing purposes.
- Perform troubleshooting, fault isolation, failure analysis, characterization, and optimization activities on a variety of electronic boards and systems.
- Create documentation in support of the design, development, characterization, and testing of board and system level components.
- Conduct measurements specified in design verification plans, document and tabulate results, and provide engineering test reports.
- Support contract manufacturers in the development and verification of assembly and test processes of printed circuit board assemblies and finished product.
- Contribute to the innovation and continual improvement of imaging performance from concept to prototyping and product release.
- Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Work closely with product development team to establish product development goals while ensuring market compatibility
- Plan, schedule and coordinate project tasks and activities.
- Support bench / animal testing and clinical evaluations.
- Identify and mitigate project risks
- Bachelor’s degree in electrical engineering, physics, biomedical engineering, or a related technical field.
- 5+ years of engineering work experience in the design and development of electrical equipment / instrumentation in a regulated environment
- Experience with the design and development of board and system level components. Specifically, FPGA based systems, switching and linear power supplies, and patient isolation circuitry.
- Experience with printed circuit board design and analysis with respect to low noise analog and digital circuits, power delivery, and EM/ESD mitigation strategies.
- Experience with the testing, debugging, and characterization, and optimization of analog and digital circuits at the board and system level.
- Experience with board and system level test method development, verification, and validation.
- Experience with the operation and use of standard and advances test and measurement equipment such as DMMs, oscilloscopes, function generators, spectrum analyzers, and network/impedance analyzers.
- Experience with the implementation and compliance testing of medical device standards: IEC 60601-1, IEC 60601-1-2, and ISO14971.
- Proficiency with board and system level documentation, including design description documents, component and board level specifications, dFMEAs, and technical reports.
- Demonstrated ability to develop new design features as part of existing systems.
- Documented record of delivering engineering information which adds value to management’s decision-making process.
- Demonstrated ability to understand and comply with applicable FDA regulations and company operating procedures, processes, policies and tasks.
- Advanced personal computer skills, including spreadsheet, word processing, database management, power point, and specialized applications such as Altium, SPICE, Minitab.
- Experience working in a broader enterprise/cross-division business unit model
- Strong individual contributor and team player in a fast-paced, changing environment.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to multitasks, prioritizes and meets deadlines in timely manner.
- Ability to engage others to accomplish projects.
- Strong organization and communication skills, with a high level of attention to detail.
- Ability to travel approximately 10%.
- Medical Device design experience – Device types II and III with type CF applied parts.
- Low noise analog and digital circuit design, debug, characterization, and optimization - isolated power supply and system level implementation.
- Design verification test method development and validation.
- Design history file documentation experience.
- Altium Designer printed circuit board design
- EMC and ESD testing and mitigation strategies
- Medical device safety standards implementation and testing - IEC 60601-1, IEC 60601-1-2, and ISO14971.
- Altera/Intel FPGA development
- Familiarity with ultrasound diagnostic, RF ablation, and cardiac mapping systems.
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