We are seeking a highly skilled and visionary Principal Electrical Engineer to lead the design, simulation, and development of complex electrical systems for our next-generation corneal cross-linking system. This role requires deep technical expertise in circuit design, simulation, PCB development, and system integration, paired with leadership in architecting solutions, mentoring teams, and ensuring compliance with medical device regulations. What You'll Do: The Principal Engineer will serve as an individual contributor, driving innovation, setting design strategy, and ensuring robust, reliable, and safe designs that meet both clinical needs and regulatory requirements. Technical Leadership
- Support the electrical system architecture and ensure seamless integration with mechanical, optical, and software subsystems.
- Act as the technical subject matter expert in circuit design, simulation, and verification by applying a systematic approach.
- Technical lead for all electrical design needs of the system development.
- Ensure adherence to FDA design control requirements (21 CFR Part 820) and compliance with applicable medical device standards (IEC 60601-1, IEC 60601-1-2).
- Mentor, coach, and provide technical guidance to junior, senior engineers and technicians.
Circuit Design & Simulation
- Lead the design of complex analog, digital, mixed-signal, RF, and power circuits for medical device applications.
- Perform advanced circuit simulations (DC, AC, transient, Monte Carlo, noise, signal integrity, power integrity, EMC/EMI modeling).
- Conduct worst-case, tolerance, and reliability analysis to anticipate failures and ensure long-term product robustness.
- Drive thermal and power distribution modeling to inform PCB layout strategies.
- Correlate simulation results with experimental data, refining models and designs for accuracy.
PCB Design & Development
- Oversee schematic capture and PCB layout using Altium Designer and other industry tools.
- Create and approve schematic symbols, footprints, and component libraries.
- Ensure PCB layouts meet signal integrity, noise immunity, EMC/EMI, creepage/clearance, and thermal requirements.
- Lead component selection for critical and electromechanical parts.
Design Verification & Validation
- Author and oversee design verification and validation protocols, ensuring compliance with product requirements.
- Lead the definition of system test plans and manage their release ECO's the EDMS (Electronic Document Management System).
- Direct bench testing of PCBs using oscilloscopes, spectrum analyzers, and other advanced instrumentation.
- Ensure traceability between requirements, design outputs, and verification results per regulatory guidelines.
System Integration & Collaboration
- Collaborate with embedded software teams to define hardware/software interface requirements.
- Drive issue resolution during system integration and clinical evaluation phases.
What We Offer
- Opportunity to lead the development of cutting-edge medical technology that directly improves patient outcomes.
- A collaborative and innovative-driven environment where your technical expertise drives product success.
- Growth opportunities into technical fellow or engineering leadership tracks.
How You'll Get There:
- Bachelor's degree in electrical engineering or related field (Master's or Ph.D. preferred).Experience:
- 10+ years of experience in electrical design and product development, with a strong track record in medical devices or other regulated industries.
- Expert-level knowledge in analog, digital, mixed-signal, and power circuit design, validated by advanced circuit simulation and modeling expertise.
- Hands-on experience with EDA and simulation tools (PSpice, LTspice, MATLAB/Simulink, Altium Designer, Allegro PCB, ORCAD).
- Proven experience in signal integrity, power integrity, EMC/EMI, and thermal simulations.
- Strong background in motor control circuits, sensors, and communication interfaces (I2C, SPI, UART, CAN, Wi-Fi, BLE).
- Experience defining and executing design verification and validation protocols under FDA design control requirements.
- Familiarity with IEC 60601-1, IEC 60601-1-2, and other applicable safety/EMC standards.
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