Senior Engineer for IVD Reliability Testing
Infostride
Job Description
Transform the MedTech 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: โข Create and implement reliability strategies for IVD devices โข Lead risk assessments through DFMEA and PFMEA โข Design and conduct HALT, HASS, and life cycle tests โข Analyze data with Weibull and lognormal models โข Manage root cause analysis and reporting processes Requirements: โข 10+ years in reliability engineering specific to MedTech โข Strong knowledge of HALT and DFMEA processes โข Experience with Minitab or JMP tools โข Familiarity with Python, MATLAB, or R is preferred โข Knowledge of ISO 13485 and FDA guidelines Leverage your reliability expertise to advance medical device safety and performance. #J-18808-Ljbffr