Senior Electronics Engineer

Job Title: Senior Electronics Engineer – Laser and Diagnostic Medical Device

Department: Research and Development – Ophthalmology Division

Reports to: CEO & Operations Director

Company Overview:

LightMed USA is a medical devices company focused on development, manufacture and marketing of innovative and versatile lasers and diagnostic devices for the Ophthalmic, Dental and Dermatology market segments.

LightMed’s business philosophy is to commit to improving quality of life by providing physicians industry’s best value devices, blending innovative technologies with ergonomic devices at unbeatable cost.

LightMed Corp was founded in 1993 and is currently offering technologies and services in over 80 countries through global distribution network and direct subsidiaries in USA, Japan, China, Korea and Taiwan.

From 2014 LightMed is establishing its Manufacturing and Development operations in USA (San Clemente, CA) and we are looking for numerous professionals to join our growing team with prospects of enduring and rewarding career opportunities.

Primary Job Function:

Senior Electronics/Firmware Engineer will work on challenging projects involving design, analysis, and testing of laser medical devices and consoles. Key responsibilities include define project requirements, developing system architecture, circuit design, schematic capture and board layout, verifying systems through analysis, fabrication, and testing, and communicate results internally and externally. The individual will bring excellent hardware design talent and firmware abilities.

  • Design electronics circuits that incorporate discrete components, MCUs, Laser or LED Drivers, Power Supplies and Communication Interfaces for embedded hardware devices.
  • Create and understand schematics, component selection, PCB layout, assembly, and test.
  • Responsible for understanding, debugging and influencing the entire embedded subsystem including embedded code, hardware, interfaces and electro-mechanical systems.
  • Responsible for programming real-time embedded systems utilizing assembly language and C code, including developing detailed requirements, design specifications, manual testing, verification and validation internally and externally through working prototypes.
  • Create structured software to meet functional, design and test requirements.
  • Develop of constant-voltage, constant-current, and/or boost power supplies.
  • Assist with specification development for design analog/digital circuits, associated microprocessor firmware, and interface with vendors/contract manufacturers.
  • Develop technical documentation and inline testing specifications for production launch.
  • Support the manufacturing team to validate electronic suppliers, and implement electrical designs in production.
  • Uncover / recognize customer needs and suggest product solution and subcontract required outside skills.

Primary Qualification/Requirements:

  • BS in Electrical Engineering preferably with a minimum of 7 years of experience in designing, programming and debugging real-time embedded control systems with various peripheral interfaces, ideally in medical device or a highly regulated environment. (MS or Ph.D.) may be substituted for work experience.
  • Demonstrated ability to solve complex design and engineering problems with minimal assistance, while drawing inputs from multiple and varied functions (i.e. Manufacturing, Quality, Regulatory, Clinical Development, etc.)
  • Demonstrated ability managing technology concept to product through design and validity of design processes. Proven experience taking a PCB concept, integrating with off the shelf or developed electrical components and following through to new product launch.
  • Design of Experiments (DOE), robust design, reliability, and tolerance allocation.
  • Demonstrated ability to work collaboratively across functional boundaries and geographies.

HARDWARE ENGINEERING

  • Expertise with various hardware electronics including MCU application, microcontroller/FPGA designs, control systems, laser interface, power systems, motor control, and wireless systems as well as computing environments and tools for circuit design and layout capture.
  • Practical experience with Microcontrollers families (ST, PIC, Atmel, TI) and associated peripherals. USART, SPI, I2C, USB, ADC, etc.
  • Strong understanding of Power Supply topologies and the different factors surrounding their design (Power Factor, Ripple, Heat Dissipation, Efficiency, etc).
  • Design, verification, and troubleshooting using basic lab instrumentation: oscilloscopes, multi-meters, emulators, spectrum analyzers, integrating spheres, photometers, goniometers, common electronics test and evaluation equipment.
  • Practical experience with communication and networking protocols (I2C, RS-232, USB, SPI)
  • Experience with 60601 standard and UL/Intertek testing, CE mark.
  • Strong troubleshooting skills to resolve ESD/EMI interference issues.
  • Experience with touch screen interface development.

FIRMWARE ENGINEERING

  • Experience with C code and assembly language programming real-time embedded systems
  • Experience with firmware development and debug, embedded OS, RTOS, embedded user interface software, interrupt driven embedded code, etc.
  • Knowledge of version control software and other configuration management tools.
  • Experience with product hardware / firmware design documentation (architecture, state diagram, module specifications).

Preferred Qualifications:

  • Ophthalmic laser driver electronics design and applications experience. Experience with Motor Control, Video/Image processing, Wireless Communications.
  • Understanding of both FDA Premarket Approval process and 510K validation process for type II and III devices.

Experience with FDA and international ISO regulations pertaining to design control, GMP, ISO 13485, EMI/EMC, and EN60601-1 as they pertain to this role.

Job Type: Full-time

Required education:

  • Bachelor’s

Required experience:

  • Electrical Engineering: 7 years
  • Ophthalmic Equipment: 5 years

United States

San Clemente, California

1130 Calle Cordillera
San Clemente, CA 92673
USA

phone 949-218-9555

fax 949 218 9556

Japan

Tokyo, Japan

3F Orchis-Takebi, 2-Chome 22-1
Hatagaya, Shibuya, Tokyo 151-0072
Japan

phone +81 3 5333 2411

fax +81 3 5333 2412