System Test Lead

3 days ago

Mississauga, Ontario, Canada Trexo Robotics Inc. Full time
About the Job

We are a fast-growing startup, Trexo Robotics Inc., and we are looking for a highly motivated System Test Lead to join our small engineering team. As the first person in the team, you will take full ownership of verification planning, test plan creation, and execution.

Key Responsibilities
  • Collaborate closely with the engineering team to understand system design in order to effectively design, develop, and execute test protocols and plans.
  • Develop and execute design verification test plans and protocols against product requirements and maintain traceability.
  • Develop engineering test methods, test fixtures, and automations, required to verify product requirements.
  • Liaise with certified test labs (e.g., CSA, TUV) to manage external verification testing.
  • Perform statistical analysis on test data to verify desired confidence and performance levels.
  • Generate and release design verification reports for internal and external testing.
  • Organize and present adequacy reviews on design verification deliverables.
  • Maintain competency in applicable standards: IEC, IEC 62304.
  • Implement exploratory testing techniques to provide early feedback during the design and development process.
  • Participate in the assessment of potential hazards and devise appropriate tests to verify mitigation of identified risks.
  • Assist with user acceptance testing with representative users and clinical evaluators.
  • Report and track product defects accurately, verify bug fixes, and ensure that other areas of product functionality are not compromised.
  • Work closely with the service team to investigate and resolve customer issues.
  • Manage test equipment to comply with calibration requirements and perform inspection and maintenance to ensure test equipment are in good working condition.
Requirements
  • Experience with design verification and validation of medical devices.
  • Knowledge of ISO 13485/21 CFR part 820.
  • Understanding of the IEC 60601 standards and their application to Medical devices.
  • 3+ years of test engineering experience, ideally in a team working on new product development.
  • Bachelor's degree in engineering (preferred: electrical, mechatronics, mechanical, or biomedical) or equivalent professional experience.
  • Experience using statistical techniques.
  • Hands-on expertise with electrical test and measurement equipment like oscilloscopes, multimeters, or signal generators.
  • Hands-on experience with electromechanical systems and root cause analysis.
  • Strong verbal and written communication skills.
  • Attention to detail.
  • Passion for end-to-end testing of software as well as hardware systems.
Preferred Qualifications
  • Experience with 510K submissions to FDA.
  • C/C++ and embedded programming skills with systems such as Arduino or Raspberry Pi.
  • Hands-on experience with SolidWorks and 3D printing/basic machining.
  • Experience working with Linux based systems.

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