- 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
- 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
Biomedical/ Electrical EngineerToronto, ON, Canada
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BIOMEDICAL/ ELECTRICAL ENGINEER
Responsible for renal pump testing, validation and tech support
Liaison between the company and manufacturer
Support the efforts of the field technicians, sales, and marketing teams that will translate into a superior customer/end user benefit
Receive in-bound shipments and perform preventive safety checks on inbound machine shipments from contract manufacturer by following appropriate SOP’s and GDP documentation.
Maintains strong technical relationship with contract manufacturer to stay current with upgrades related to machine design - software/electrical
Work as a liaison between local QA and contract manufacturer to ensure new build machines satisfy USA and Canadian regulatory and manufacturing agreements
Work closely with Regulatory department to support submission of approval documents to health authorities, maintain and update the product design history files
Support a wider range of engineering activities such as testing, modification, fabrication and assembly under limited direction from Engineers; and may propose technical solutions
Leads the coordination of testing/validation/verification of machines with appropriate regulatory bodies in Canada and the U.S.A.
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
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
Perform more complex work using drawings, diagrams, written and verbal instructions, layouts or defined plans to perform testing, checkout, and trouble-shooting functions
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
Category: Biotechnology & Pharmaceutical
Reference ID: CA7677BM001340
Date Posted: 13/03/2019