R&D Systems Engineer

6 days ago

Old Toronto, Ontario, Canada KNG Technical Inc. Full time
About the Role

KNG Technical Inc. is seeking a highly skilled R&D Systems Engineer to join our team in driving the integration of instrumentation to develop innovative high technology products for the human diagnostic market.

Key Responsibilities
  • Instrumentation Integration: Develop and execute qualification procedures for complex fluidic, mechanical, and optical instrumentation systems.
  • Design and Development: Participate in designing and developing new diagnostic instrumentation, collaborating with scientists, engineers, and software developers across various disciplines.
  • Technical Documentation: Write technical design documents according to set standards and guidelines within a regulated medical device quality framework.
  • Script Development: Design, develop, and verify medical device scripts that connect and control third-party automated hardware components.
  • Verification and Validation: Develop and execute verification and validation protocols and reports supporting current instrumentation system designs and design changes within FDA, Health Canada, and ISO 13485 regulations.
  • Team Collaboration: Integrate instrumentation development, design improvements, and testing practices with the Software Development Team, managing activities via electronic service tickets in JIRA.
  • Problem-Solving: Investigate and resolve reported system issues within the Quality Management System (CAPAs, customer complaints, deviations, etc.), including conducting root cause analyses and risk assessments, planning and executing corrections and corrective/preventative actions, writing investigation reports, and initiating Supplier Corrective Action Reports (SCARs).
Requirements
  • Education: Undergraduate degree in Systems, Mechanical, Mechatronics, or related Engineering field.
  • Experience: Minimum 3 years' experience in a regulated diagnostic, biotechnology, or medical device company, preferably one with exposure to automation.
  • Programming Skills: Programming experience in C, C#, or Python is required.
  • CAD and Instrumentation Design: Knowledge of CAD and instrumentation design.
  • Documentation and Data Analysis: Ability to create documentation (e.g., verification and validation protocols) within a Quality Management System and analyze and summarize experimental data.
  • Professional Engineer License: Professional Engineer (P.Eng.) license is preferred.
Additional Requirements
  • Strong Work Ethic and Organizational Skills: Strong work ethic and organizational skills; highly-motivated; conscientious; ability to work both independently and as a team player.
  • Excellent Communication Skills: Excellent oral and written communication skills.
  • Fluorescence Scanner Qualification: Experience with Fluorescence scanner qualification.
  • Technical Requirements and Specifications: Ability to define and interpret technical requirements and specifications for new/next-generation instruments, especially in areas related to controls, firmware, and software.
  • Collaboration and Adaptability: Ability to effectively collaborate with programmers, engineers, scientists, and production management during the entire life cycle of system development, and willingness to learn new skills and attention to detail.
  • Hamilton Liquid Handling Platforms: Experience programming Hamilton liquid handling platforms, including creation of HSL libraries.
  • Source Code Control: Experience utilizing source code control (SourceTree, git).

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