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Electrical Engineer - Medical Device

Cincinnati, OH
My customer has an immediate need for a Electrical Engineer in their R&D group.

The R&D Electrical Engineer will manage the specification, design and development of electrical circuits and the selection of electrical and electronic components for medical devices. The R&D Electrical Engineer will work with internal design teams, and outside co-development partners and suppliers, with responsibility for full electrical architecture and design for new products.
 
Requirements for R&D Electrical Engineer:
 
  • Bachelor's degree in electrical engineering, MS preferred
  • 7+ years demonstrated experience with circuit design for embedded systems; experience with embedded microcontrollers, PLD/FPGA, bus protocols (such as RS232, I2C, CAN, Ethernet), motor drivers, converters and amplifier circuits, filter design, pulse width modulation, transceivers and switching power supplies.
  • Experience with outsourced developments and ability to identify and select co-development partners and suppliers that meet business standards.
  • Experience with vendor management; including purchasing, RFQs, PCB fabrication/assembly services.Strong analytical and critical thinking skills and knowledge of problem-solving techniques.
  • A working understanding of IoT
  • Proficient use with computer aided design software (i.e. Alum)
  • Working knowledge of design programs AutoCAD and SolidWorks a plus.
  • Knowledge of leading manufacturing processes relevant in the electromechanical medical devices industry with a focus on PCB manufacturing, assembly and cabling.
  • Understanding of design control processes following ISO13485 or FDA 21 CFR 820 “Design Control Guidance For Medical Device Manufacturers”.
  • Excellent knowledge of EN60601-1 standard and functional safety requirements.Ability to identify, analyze and implement improvements independently and to propose changes to existing methods, procedures, processes and/or products.Use of project management skills throughout the project concept, feasibility. development, qualification and launch
  • Knowledge of EMI and ESD test methods.
  • Experience with automated testing and knowledge of Design For Testability techniques.
 The R&D Electrical Engineer will: 
  • Identify and organize the selection of key partners for co-development, prototyping and manage outsourced developments.
  • Design and develop new PCBAs for new medical devices and provide support for existing production released products.
  • Ensure that all product development conforms to the requirements of  design control procedures.
  • Prepare and approve hardware development documentation, including product requirements, design specifications, and verification protocols.
  • Conduct and or supervise verification and validation testing, and document testing results.
  • Participate in risk management process, including preparation of risk analysis and FMEA.
  • Provide technical support for product changes and new product manufacturing requirements.
  • Develop and implement project plans from concept through feasibility, development, qualification and launch.
  • Work with software engineering team to develop PCBA by selecting the appropriate components with regards to embedded software requirements.

 

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