Hardware Design Engineer

Senior/Staff Electrical Engineer – for Medical Devices (San Diego, CA)

As a member of an international cross-functional team, you work closely together with electrical engineers, transducer engineers, system engineers, and ultrasound engineers on the development of Intravascular Ultrasound Systems.

Your role:

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• Conceptualizing, designing, and developing analog and digital PCBAs and FPGAs.
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• Collaborating with multi-disciplinary teams, including marketing, hardware, software, catheter design, and manufacturing, to refine design requirements for next-generation intravascular ultrasound devices.
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• Responsibilities include specifying and qualifying components, equipment, and design tools based on analyses of design specifications, costs, availability, and reliability, and integrating these into both new and existing designs to optimize performance and efficacy.
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• Performing tests and debugging designs while maintaining comprehensive documentation aligned with the quality system to support the seamless transition from design to production, adhering to established development procedures.
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• Leading the creation and execution of formal verification and validation plans in collaboration with Quality and Regulatory teams, actively participating in transferring designs from R&D to manufacturing and conducting technical design reviews with project teams and independent experts.
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You're the right fit if:

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• You've acquired 5+ years of experience in the design and development of analog and digital electronics and FPGAs, preferably within medical electronics. Strong background is HDL is required.
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• Your skills include proficiency with FPGA design tools, schematic capture software, oscilloscopes, logic analyzers, emulators, and other lab equipment for testing and debugging electronic designs. Experience with electromagnetic compatibility (EMC), electrostatic discharge (ESD), and signal integrity testing to international standards is required, and familiarity with embedded software development is a bonus.
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• You have a BS/MS in Electrical Engineering, Biomedical Engineering, or a related field. Experience applying IEC 60601-1 and related medical device electronics standards is desirable. .
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• Preferred Skills:
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• Product Development Lifecycle Management
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• Verification Testing
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• Validation Testing
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• Technical Documentation
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• Research & Analysis
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• Technical Acumen
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• Product Design
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• Quality Specifications
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• Regulatory Requirements
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• Troubleshooting
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• Requirements Analysis
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• Hardware Engineering
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• Business Acumen
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• Continuous Improvement
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• Stakeholder Management
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