Hardware Engineer

4 weeks ago

Toronto, Canada Vivosonic Inc. Full time

The Company:

Vivosonic Inc. is a small manufacturing company in Toronto that develops, manufactures and markets medical devices for auditory diagnostic measurement and newborn hearing screening. The Company is a leader in the development of innovative technologies to enhance auditory evoked response detection. These products are sold through a global distributor network in over 55 countries. The Company's core competencies are advanced signal processing and filtering techniques for the analysis of electrophysiological responses and these strengths provide a clear competitive advantage in ABR detection.

Position Overview:

Job Title:  Medical Device Hardware Engineer

Supervisor: The position reports directly to the VP of Operations

Job Description:

We are looking to expand our engineering team with a committed and enthusiastic hardware engineer. You will be responsible for designing new electrical hardware products and improvements to existing components for our medical device product. You will be involved in procuring and validating designs and developing manufacturing test approaches for the developments. Your work will also include the development of embedded firmware. The Medical Device Hardware Engineer will apply sound engineering principles and approaches to the development of our advanced audiology diagnostic and screening equipment.

The Hardware Engineer will be responsible for producing electrical and electronic designs, design specifications and test documents following the Company’s Quality System and established Medical Device standards.  You’ll have working knowledge of electrical safety testing and the ability to lead projects to a successful and timely completion.

The successful candidate must be:

·      A logical thinker with creative problem-solving abilities.

·      Able to work well with others,

·      Be driven to continuously improve,

·      Willing to share knowledge with others,

·      Able to take initiative.

Responsibilities:

·      Electrical Engineering design

  • Leads electrical design in accordance with applicable standards and safety requirements.
  • Performing FMEA for hardware component failure
  • Recommend new hardware designs and generate specifications
  • Design and test circuits and other electronic components.
  • Design embedded firmware/software for the products (FPGA/DSP)
  • Performing tests of new hardware.
  • Troubleshooting and debugging performance issues to support production and customer support.
  • Working with vendors and hardware suppliers to implement new designs.
  • Supporting the Research and Development team
  • Evaluate the effectiveness of the design and change if necessary.
  • Estimate cost, reliability, and safety factors.
  • Build, test and modify product prototypes.

·      Quality

  • Ensure that Documents and Test Records produced by Hardware Engineering comply with The Company’s Quality System.
  • Ensure that all quality regulations (MDSAP, ISO 13485 and IEC 62304) are followed for all hardware development activities.

Skills and Knowledge:

  • Advanced knowledge in Analog/Digital circuitry design specifically analog circuitry analysis and simulation.
  •  Knowledge of and experience with analog filters, Bluetooth communications protocols including SPI, UART, I2C and mechanical design a significant asset. 
  • Design experience for Reliability (DFR), Design for Manufacturability (DFM), and Design for Test (DFT).
  • PCB Design including schematic capture, layout, and manufacturing for BGAs and mixed signal PCBs.
  • Excellent documentation and progress tracking skills.
  • Good communication skills to clearly articulate design principles and problems.

Experience:

  • At least tree (3) years in electrical design.
  • Experience creating schematics, determining component selection (including replacement of obsolete parts), and driving layout of printed circuits using Altium tools. (CAD)
  • At least two (2) years in electrical design with medical device standards a strong asset.
  • Experience working with medical device standards such as ISO 13485, ISO 14971, IEC 60601, competency working with MDSAP Quality Regulations and Current Good Manufacturing Practices.

 Education:

  • Bachelor’s or Master’s degree in electrical engineering or related field and 3+ years of relevant experience in hardware design and development in a heavily regulated environment, preferably medical device. A combination of education and experience may be considered.

Job Type:

Permanent - Full-time

·      This position requires the candidate to work in the office 5 days per week.

·     The candidate must be a Canadian citizen or else have a valid work permit that allows the candidate to work in Canada for an unlimited time.


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