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System Test Lead

unlimited holidays - extra holidays - fully flexible
Remote: 
Hybrid
Experience: 
Mid-level (2-5 years)
Work from: 
Mississauga (CA)

Offer summary

Qualifications:

Bachelor's degree in engineering preferred., 3+ years of test engineering experience., Experience with design verification of medical devices., Knowledge of ISO 13485 and CFR regulations..

Key responsabilities:

  • Develop and execute test plans and protocols.
  • Conduct comprehensive software and hardware testing.
Trexo Robotics logo
Trexo Robotics Medical Device TPE https://www.trexorobotics.com/
11 - 50 Employees
See more Trexo Robotics offers

Job description

About us

Trexo Robotics is enabling mobility by building powered wearable robots. Our first product is a robot for children with movement disorders such as Cerebral Palsy, and it allows kids to walk, in many cases, for the first time in their lives. The device is currently being used by hundreds of families and the best hospitals across North America.

We are constantly working towards building mobility solutions for all. At Trexo Robotics, you will find a flat organization where you can work with highly optimistic, low ego, and exceptionally talented individuals who look forward to solving hard problems.

About the job

We are a fast-growing startup and are looking for a highly motivated System Test Lead. As part of our small engineering team, you will be responsible for complete product design verification, this includes testing various layers of custom software and hardware individually and as a whole integrated system. As the first person in the team, you will take full ownership of verification planning, test plan creation and execution.

This position is hybrid (3 days in the Mississauga office).


About you

If you are someone who wants to work in a small team to solve a big problem, and you have a passion for system testing and verification. The idea of revolutionizing multiple industries excites you, and you have the ability to handle multiple tasks simultaneously with excellent task management skills. You pay attention to detail and enjoy asking "why" multiple times until you understand something from its core principles.

What you will do:
  • 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.

  • Conduct comprehensive software and hardware testing of Trexo’s products.

  • 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 60601-1, 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.

Required skills:
  • Experience with design verification and validation of medical devices.

  • Knowledge of ISO 13485/21 CFR part 820.

  • 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.

Nice to have:
  • Experience with 510K submissions to FDA.

  • Understanding of the IEC 60601 standards and their application to Medical devices.

  • 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.

Compensation and Benefits
  • Employee stock options.

  • Unlimited Vacation policy.

  • Group benefits plan (100% covered by the company).

  • Snacks in the office.

  • Dog friendly office.

Please note that at this time, we can only consider applicants who are already eligible to work in Canada and we are unable to provide relocation support. We appreciate your understanding and look forward to receiving your application.

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Industry :
Medical Device
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Detail Oriented

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