"Alerted.org

Principal Electrical Design Engineer

Requisition Number **2906**

Location **US - Marlborough, MA**

State/Territory **Massachusetts**

General Summary

The Principal Electrical Engineer is responsible for the design and specifications of electrical and electronic hardware for Laser and RF energy based aesthetic medical devices. Work in a multi-disciplinary environment acting as the lead for critical design and development activities for all electronic hardware including analog, digital and power devices. Understands Compliance Regulations ensuring development adheres to Candela business requirements.

Essential Job Functions

• Provide subject matter expertise and work collaboratively with mechanical, software, opto-mechanical and system engineers in a hands-on new product development environment.

• Design analog, digital and power circuits for embedded microcontroller-based systems.

• Design electronic circuits for electro-mechanical systems that include solenoids, fans, heaters, motors, sensors, transducers etc.

• Design high voltage and high current driver circuits for flashlamp based laser devices.

• Design power and control circuits related to delivery of RF energy for aesthetic medical devices

• Design and/or oversee printed circuit board layout.

• Generate and execute test plans to validate accuracy of new designs.

• Directly responsible for overall product design meeting global IEC 60601-1 safety approval.

• Shepherd products through IEC 60601 approval process. Provide hands on support working with off-site test agencies to obtain regulatory approval.

• Support risk management activities related to IEC 14971

• Identify and supervise appropriate test methods for both prototype and production-level hardware

• Engage in intra-company collaboration between electrical, firmware, mechanical, opto-mechanical, manufacturing, field service and operations

• May supervise and/or coach other engineers and technicians with an eye toward their continued development and the overall performance of the electrical engineering team.

• Conduct product design control activities for new and sustaining product development efforts

• Work with Research to formulate concepts for new or enhanced products and architectures

• Preside over comprehensive design reviews and ensure that projects are maintained to the product development process.

• Makes technological and architectural decisions

• Provides recommendations on development partners, hiring of temporary or permanent resources, and the procurement of equipment.

• Work across engineering functions to define, architect, and direct the implementation of projects related to aesthetic laser systems and accessories.

• Work cross functionally (marketing, clinical, service, manufacturing, regulatory, and quality organizations) to identify and document product requirements.

• Responsiblefor the design of analog, digital and power electronics for medical products. May participate in or lead quality improvement initiatives for existing products.

•Experience with the design of signal conditioning circuits for transducers, familiar with designing electronics for electro-mechanical systems that include solenoids, fans, heaters, motors, sensors, etc.

•Design high voltage and high-power circuits for laser diodes and flashlamp pumped lasers.

•Work collaboratively with engineering team of mechanical, software and optical engineers in a hands-on new product development environment.

•Design and/or oversee printed circuit board layout.

•Designs may include CPLD or FPGA design.

•Generate and execute tests to verify accuracy of designs. Knowledge of HALT, HASS and other reliability test methods.

•Knowledge of design requirements to meet FDA & IEC 60601-1 Medical safety and EMC approvals. Work directly with safety agencies to obtain approvals for new products.

•Developing compliance plans and evaluating new methodologies.

•Preparing and submitting required documentation to governance bodies.

• Ability to lead projects and work independently

Knowledge/Educational Requirements

• Requires BSEE degree and a minimum of 10 years’ experience in new product development environment.

• Experience working on Medical Devices or regulated environments

•Working knowledge of FDA, IEC and UL standards relating to medical devices

• Capable of executing component level design of microcontroller-based products, HV power supply, laser drivers and other system peripherals within complex capital equipment style medical device.

• Experienced with designing for multi-processor communications including 1-wire, SPI, I2C, RS232, RS485, USB, Canbus, etc.

• Working knowledge of ORCAD Schematic Capture.

• Experience with printed circuit layout process /Proficient using OrCAD PCB Editor helpful

• Experience with PCB layout related to RF/EMI/EMC/ESD mitigation techniques

• Knowledge of CPLD or FPGA design

•Familiar with PSPICE simulation software or equivalent

• Experienced with resonant and non-resonant Power RF design techniques.

• Knowledgeable in power delivery and isolation techniques to support type “BF” applied parts

• Monopolar and Bipolar RF design techniques.

• Knowledge of power switching components including MOSFET, GaN or SiC power device and DC/DC converter and inverter design

• Provide expert-level guidance on the application of IEC 60601-1 standards with emphasis on electrical safety, EMC, and mechanical safety.

• Knowledge of magnetics design and digital/analog closed loop control