Work closely together with electrical engineers, transducer engineers, system engineers, and ultrasound engineers on the development of Medical Device Intravascular Ultrasound Systems.
Duties:
- Conceptualize, design, and develop analog and digital PCBAs and FPGAs.
- Collaborate with multi-disciplinary teams, including marketing, hardware, software, catheter design, and manufacturing, to refine design requirements for next-generation intravascular ultrasound devices.
- Specify and qualify 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.
- Perform 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.
- Lead 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.
Required Skills/education
- 8+ 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.
- 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.
- BS/MS in Electrical Engineering, Biomedical Engineering, or a related field. Experience applying IEC 60601-1 and related medical device electronics standards is desirable. .
- Preferred Skills:
- Product Development Lifecycle Management