Candela Medical · 1 week ago
Principal Electrical Design Engineer
Marlborough, MA
Full-time
Onsite
Lead/Staff
10+ years expCandela Medical is focused on developing innovative aesthetic medical devices, and they are seeking a Principal Electrical Design Engineer to lead the design and specifications of electrical and electronic hardware. The role involves collaborating with multidisciplinary teams to develop embedded systems and ensuring compliance with safety regulations.
Medical Device
Hiring Manager
Hannah Chadwick (Elrick)
Responsibilities
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
Responsible for 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
Qualification
Required
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
Company
Candela Medical
Candela’s brand values of Science, Results, and Trust guide its commitment to safety, efficacy, reliability and strengthening the longstanding partnerships of trust established with physicians, their practices and the patients they treat.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Ernie Orticerio
Chief Financial Officer
Robert Blood
Executive Vice President, Chief Legal Officer and General Counsel
Company data provided by crunchbase