Principal Electrical Engineer

Our client, a global medical device company, is looking for a Principal Electrical Engineer to join their team. In this role you will lead the design, development, and validation of electrical and electronic hardware for laser- and RF-based aesthetic medical devices. This role operates in a highly cross-functional, regulated environment and serves as the technical authority for analog, digital, power, and high-voltage electronics. The position ensures all designs meet global safety, quality, and compliance requirements while advancing product innovation and architectural excellence.

Responsibilities

• Provide subject matter expertise and collaborate closely with mechanical, software, optical/opto-mechanical, and systems engineers in a hands-on new product development environment.
• Design analog, digital, and power electronics for embedded microcontroller-based medical systems.
• Design electronic circuits for electro-mechanical systems including solenoids, fans, heaters, motors, sensors, and transducers.
• Design high-voltage and high-current driver circuits for laser diodes and flashlamp-pumped laser systems.
• Design power and control circuitry for RF energy delivery used in aesthetic medical devices (monopolar and bipolar RF).
• Design and/or oversee printed circuit board (PCB) layout with attention to RF/EMI/EMC/ESD mitigation.
• Develop, execute, and supervise test plans to validate prototype and production-level hardware; apply HALT, HASS, and other reliability test methods.
• Lead overall product electrical design to meet FDA and global IEC 60601-1 safety and EMC requirements.
• Shepherd products through IEC 60601 approval, working directly with external test labs and regulatory agencies.
• Support risk management activities in accordance with ISO 14971.
• Conduct product design control activities for both new and sustaining product development.
• Preside over comprehensive design reviews and ensure adherence to the product development process.
• Make key technological and architectural decisions across projects.
• Work cross-functionally with marketing, clinical, service, manufacturing, regulatory, quality, and operations teams to define and document product requirements.
• Collaborate with Research to develop concepts for new products, enhancements, and system architectures.
• Provide recommendations regarding development partners, staffing (temporary or permanent), and equipment procurement.
• Lead projects independently and/or supervise and mentor engineers and technicians to support team development and performance.
• Prepare, maintain, and submit technical and compliance documentation to internal and external governance bodies.
• Participate in or lead quality improvement initiatives for existing products.

Requirements

• BSEE required with a minimum of 10 years of experience in a regulated new product development environment.
• Prior experience designing medical devices or working in highly regulated industries.
• Expert working knowledge of FDA, IEC, and UL standards applicable to medical devices, with emphasis on IEC 60601-1.
• Proven experience with component-level design of complex medical capital equipment, including:
  • Microcontroller-based systems
  • High-voltage power supplies
  • Laser drivers and RF power systems
• Experience with multi-processor and system communications (1-Wire, SPI, I²C, RS-232, RS-485, USB, CANbus).
• Proficient in OrCAD Schematic Capture; experience with OrCAD PCB Editor preferred.
• Strong background in PCB layout and design for RF, EMI/EMC, and ESD performance.
• Familiarity with PSPICE or equivalent circuit simulation tools.
• Experience with CPLD and/or FPGA-based designs.
• Knowledge of resonant and non-resonant RF power design techniques.
• Expertise in power delivery, isolation, and patient-applied part design (Type BF).
• Experience with power switching technologies including MOSFETs, GaN, and SiC devices, as well as DC/DC converters and inverter design.
• Knowledge of magnetics design and digital/analog closed-loop control systems.
• Demonstrated ability to lead projects, work independently, and provide expert technical guidance across disciplines.