Biomedical/ Electrical Engineer

    Toronto, ON, Canada
    • BSc in Electrical, Biomedical, Mechanical, Mechatronics, Computer Science, etc.
    • 0-1 year co-op experience working with electrical systems and/or medical devices
    • Knowledge of electrical safety rules; ISO 13485 an asset

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    BIOMEDICAL/ ELECTRICAL ENGINEER

    Responsible for renal pump testing, validation and tech support

    Liaison between the company and manufacturer

     

    RESPONSIBILITIES

    1

    Support the efforts of the field technicians, sales, and marketing teams that will translate into a superior customer/end user benefit

    2

    Receive in-bound shipments and perform preventive safety checks on inbound machine shipments from contract manufacturer by following appropriate SOP’s and GDP documentation.

    3

    Maintains strong technical relationship with contract manufacturer to stay current with upgrades related to machine design - software/electrical

    4

    Work as a liaison between local QA and contract manufacturer to ensure new build machines satisfy USA and Canadian regulatory and manufacturing agreements

    5

    Work closely with Regulatory department to support submission of approval documents to health authorities, maintain and update the product design history files

    6

    Support a wider range of engineering activities such as testing, modification, fabrication and assembly under limited direction from Engineers; and may propose technical solutions

    7

    Leads the coordination of testing/validation/verification of machines with appropriate regulatory bodies in Canada and the U.S.A.

    8

    Check for failures in equipment and perform corrective actions to affected areas that have down time, including conducting and writing impact assessment reports of incidents

    9

    Execute experiments and tests (following protocols) to develop findings for the validation and improvement of equipment and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports for Engineering review

    10

    Perform more complex work using drawings, diagrams, written and verbal instructions, layouts or defined plans to perform testing, checkout, and trouble-shooting functions

    11

    Review documentation and take appropriate actions to ensure that information is appropriately catalogued and follow through to validation and qualification of equipment, including transferring information to appropriate locations, e.g., Design History File, SOPs, GDPs, and drawings, for Engineering approval

      

    REQUIREMENTS

    • Bachelor's degree in Biomedical, Computer Science, Electrical or Mechanical Engineering or related field, or an equivalent combination of training and experience is desirable.
    • 0 – 1 year in a technical engineering role with hands on experience

    • New Engineering Graduate with strong summer job experience in a technical role in regulated environments

    • Excellent English proficiency – oral and written

    • Excellent English and grammar skills
    • Ability to write and read technical reports
    • Ability to read electrical schematics and use basic electrical testing instruments
    • Excellent computer skills – Microsoft Office Word, Excel, and PowerPoint
    • Ability to utilize CAD/CAM software packages

     

     

     

     

      

     


    Category: Biotechnology & Pharmaceutical

    Reference ID: CA7677BM001340

    Date Posted: 13/03/2019

    Shortcut: http://jobs.en.kellyservices.ca/BHUxmr

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