Canada-ON-Hamilton/St.Catherines; Canada-QC-Montreal
About the role:
As a R&D Test Engineer II, you will play a crucial role in ensuring the quality and reliability of our medical device products. You’ll collaborate with cross-functional teams to design, develop, and execute comprehensive test plans, ensuring compliance with industry standards and regulations. Your work will directly impact patient safety and contribute to life-changing solutions.
This is a hybrid position based out of Montreal, Canada with the expectation to be in the office a minimum of three days per week.
Your responsibilities will include:
- Analyze system requirements to design and develop test plans and protocols to ensure designs meet requirements.
- Conduct engineering and design performance tests.
- Analyze test results, detect issues and track root causes.
- Develop engineering and design verification test reports.
- Work with a cross-functional team.
- Ensure compliance of project deliverables to GSM and supports system owners during external audits.
- Work independently to plan and schedule own activities necessary to meet timelines, and communicate in a timely manner.
Required Qualifications:
- Undergraduate or master's degree in engineering or related field.
- 2+ years of relevant test engineering experience.
- Strong problem-solving skills in a team environment.
- An analytical and quantitative approach to work, as well as the confidence to influence people at all levels.
- Excellent organizational, planning, communication and collaboration skills.
- Strong documentation skills.
Preferred Qualifications:
- Technical knowledge of testing concepts for electrical/electro-mechanical equipment.
- Knowledge of ISO 13485 and FDA 21 CFR Part 820.
- Knowledge of ISO 14971.
- Knowledge of IEC 60601 series of standards.