San Francisco Bay Area
Principal Systems and Electrical Engineer contributing to the development and implementation of advanced electronics, firmware, and systems for next-generation medical and life science devices. Decades of experience in systems-level design and integration, demonstrated leadership in delivering complex medical device solutions, including pulse-field ablation systems and neurostimulators. Known for combining technical expertise in robotics, control theory, and power electronics with effective project management, fostering collaboration to meet stringent industry standards. Passionate about driving innovation in medical technology to improve patient outcomes and operational efficiencies.
Developed and implemented all electronics and systems for next generation cell therapy manufacturing and research. This system called the cell shuttle comprised of hundreds of discrete electronics and PCBAs that was ultimately controlled by a single processing unit which could be networked with other systems seamlessly. The instruments are subsystems that are responsible for complex coordination of HV pulses, temperature and pressure regulation, fluid transfer rates ultimately leading up to a reliable and repeatable process. • Lead development and transition of next generation of fully embedded electronics using Linux and real-time OS on MCUs for more precision and faster response times. • Implemented embedded C firmware MCU to coordinate control and measurements with various interfaces: I2C, SPI, UART, analog in/out, PWM, Modbus. • Designed with Altium, procured, bring-up, and released all PCBAs and custom electronics for company. • Designed embedded firmware architecture for performance and lower costs compared to previously. • Implemented and tuned control loops for motion, temperature, pressure, voltage, and current. • Architected and designed next-generation electroporation/EP capable of usec voltage pulses of 1000V. • Coordinate cross-functional integration of systems, electrical, controls, embedded, software, and cloud. • Evaluated components to meet strict requirements on functional safety, high-power consumption, high-voltage tolerances, motor control, precise temperature and pressure regulation. • Applied 1st principal concepts across MVP, future proofing, safety and reliability, manufacturability, etc. • Evaluated risks and compliance to life-science and bio standards especially to IEC 61010. • Wrote GUI using Python to allow for seamless access to Modbus registers enabling control over motion, control system parameters, thermoelectric coolers/TEC, and sensor measurement data.
Lead development of all electronics and systems of medical device capital equipment and supported neurostimulator integrated circuit ASIC and electronics. The capital equipment included medical pulse-field ablation (PFA) capable of generating up to 3kV at 80A biphasic pulse outputs on 16-channels and health diagnostic devices used in clinics. The PFA device was intended for treating arrythmia (irregular heartbeats) using highvoltage pulses. The outcome was successful delivery of 12 clinical systems that went through V&V and manufacturing qualifications to meet stringent standards and medical requirements. • Designed and tested PCBA responsible for delivering 3kV at 80A biphasic pulses which consisted of 10 unique circuit boards of high complexity. • Facilitated architectural design of PFA 3kV system involving 12 engineers internally and externally. • Evaluated and selected components which included IGBTs, power MOSFETS, and HV generator. • Developed system and electrical engineer test methods for verification. • Interfaced with compliance agencies to conduct evaluation of the system against IEC 60601-1, 60601-1-2, 62304, 60601-2-2 (electrosurgical standard). • Conducted de-risking tests for evaluating feasibility of high-power relay welding risks, pulse current limiting resistors, leakage current of isolating circuits, and high-voltage breakdown issues. • Developed complete system to subsystem requirements and test methods tracing and trained team. • Interfaced with broader team to work on common BLE, ASIC, and neurostimulator company approach. • Developed characterization plans in parallel to converge on requirements that have not been finalized. • Deployed manufacturing final tests in parallel of developing and design systems. • Programmed test scripts and automation using Python, NI, and STM32 firmware to support engineering bring up, compliance pretests, and manufacturing final tests.
Led electrical development and verification on next generation neurostimulator. Managed cross-functional teams to meeting goals for requirements, planning, risk management, electronics deliverables, verification/validation, manufacturing testing and transfer, and sustaining activities. Planning for essential performance and testing was done to IEC 60601-1, 60601-1-2, ISO 14708, FCC/RED, Bluetooth SIG, and FDA Cybersecurity guidance standards. Development of electronics included new microcontroller, ASIC, and RF signal chain as well as leveraging prior wireless battery charging. Characterized next generation stimulation waveforms, RF telemetry performance, impedance measurements, and battery power consumption. Led systems V&V planning and execution in parallel with development of final firmware and electronics. • Designed INS electronics which includes: a custom ASIC, BLE 4.2, magnetic detection, etc. • Responsible for custom ASIC chip for delivering safe and reliable therapy in many configurations. • Programmed BLE software (python) for verification purposes. • Designed and executed V&V planning for INS in parallel with manufacturing transfer. • Coordinated with quality, regulatory, manufacturing, firmware, software, and mechanical team. • Characterize all subsystems: battery power consumption, wireless battery charger, current pulser, and telemetry (BLE in phantom) performances. • Executed immunity testing: MRI, X-rays, ultrasound, radiated, magnetic, RFID, SAR, wireless coexistence.
Led team responsible for all electrical subsystems including safety, high voltage power supplies, communications and programmable logic designs and implementation for Cutera’s next generation laser devices used on transdermal procedures. Deliverables were successful 510k submission for next generation Enlighten systems and pilot production releases. Lead R&D effort on next-generation body-shaping product. Scope of project included designing architecture, staffing resources for hardware development, generating budgetary and schedule information, regulatory submission, and planning for production release. ● Defined strategy and approach to integrating electronics with optics, software, and mechanical engineering teams ● Coordinated participation between engineering, quality, and regulatory for updating SOP, WI ● Defined product specifications from design requirements that was derived from clinical input ● Lead transfer of Excel V, Enlighten, and Trusculpt pilot and production release ● Organized effort for improving product reliability between 5 functional teams for all product families ● Planning and execution of electrical safety/EMC related clinical VnV and IEC 60601-1 testing including debugging EMI at TUV and related test facilities ● Designed electrical architecture with 800V-1200V power supplies for driving laser amplifiers for aesthetic treatment and RF amplifiers for circumferential reduction procedures ● Responsible for transferring electronics to production/CM and running cost reduction programs ● Incorporated design constraints around scope, schedule, budget, regulatory, manufacturability and serviceability ● Designed architecture for Trusculpt RF amplifier system and successfully transferred to manufacturing
Developed and implemented the electrical architecture for a next generation robotically driven surgical device – featuring 100+ DOF motion control. Electronic subsystems include power distribution, motor controllers, battery management, fault protection, functional safety, reliable system communications, and camera/image processing. Recruited and functionally managed EE team to meet company goals. All design and development was done per IEC 60601-1/FDA guidelines. Planned and lead successful electrical safety and EMC testing which resulted in 510k clearance for Auris. ● Designed robotic electrical architecture incorporating reliable power distribution and communications ● Collaborated with software and mechanical teams in defining the system architecture and risk mitigation ● Mapped out high-level customer requirements to engineering design input requirements ● Developed schedule, risk, and budget plans for scope of the project and reiterated plans based on priority ● Built and trained electrical team from the ground up with collaboration from internal/ external recruiters ● Coordinated efforts with QA/compliance consultants for gap and hazard analysis on 510k submission ● Lead co-development of multi-axis instrument manipulator electronics used with robot arms ● Developed specifications for robotic system power/energy budget, latency, and data throughput ● Generated FMEA that included potential electrical faults and patient safety in the robotic system