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R&D Systems Engineer

1 month ago

Old Toronto, Ontario, Canada KNG Technical Inc. Full time
Job Title: R&D Systems Engineer

KNG Technical Inc. is seeking a highly motivated and experienced R&D Systems Engineer to join our team. As a key member of our engineering team, you will be responsible for driving the integration of instrumentation to develop innovative high technology products for the human diagnostic market.

Key Responsibilities:
  • Analyze and design automated diagnostics instrumentation from a systems engineering perspective, incorporating fluidic, mechanical, and optics hardware components that integrate with our proprietary software.
  • Collaborate with scientists, engineers, and software developers to design and execute study protocols for product integration and optimization.
  • Develop and execute verification and validation protocols and reports, ensuring compliance with FDA, Health Canada, and ISO 13485 regulations.
  • Design, develop, and verify medical device scripts that connect and control third-party automated hardware components.
  • Investigate and resolve reported system issues, conducting root cause analyses and risk assessments, and planning and executing corrections and corrective/preventative actions.
Requirements:
  • Undergraduate degree in Systems, Mechanical, Mechatronics, or related Engineering field.
  • Minimum 3 years' experience in a regulated diagnostic, biotechnology, or medical device company, preferably with exposure to automation.
  • Programming experience in C, C#, or Python is required.
  • Knowledge of CAD and instrumentation design.
  • Ability to create documentation within a Quality Management System and analyze and summarize experimental data.
Preferred Qualifications:
  • Professional Engineer (P.Eng.) license.
  • Experience with Fluorescence scanner qualification.
  • Ability to effectively collaborate with programmers, engineers, scientists, and production management during system development.
What We Offer:
  • A dynamic and innovative work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.