Senior Engineer IVD Reliability Testing

Position: Senior Engineer for IVD Reliability Testing
Transform the Med Tech industry as a Senior Engineer focusing on reliability testing for IVD products in Ottawa, Ontario. Your leadership will be crucial in ensuring product safety and compliance through rigorous testing methodologies.

With at least 10 years of experience, you'll spearhead the development of reliability strategies. The role involves designing tests and fixtures, performing intricate statistical analyses, and leading DFMEA and PFMEA activities. You will also collaborate with cross-functional teams to foster a culture of reliability and quality.

Key Responsibilities:

• Create and implement reliability strategies for IVD devices

• Lead risk assessments through DFMEA and PFMEA

• Design and conduct HALT, HASS, and life cycle tests

• Analyze data with Weibull and lognormal models

• Manage root cause analysis and reporting processes

Requirements:

• 10+ years in reliability engineering specific to Med Tech

• Strong knowledge of HALT and DFMEA processes

• Experience with Minitab or JMP tools

• Familiarity with Python, MATLAB, or R is preferred

• Knowledge of ISO 13485 and FDA guidelines

Leverage your reliability expertise to advance medical device safety and performance.
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