Senior Medical Device Reliability Engineer
Employment International
Job Description
Advance your career as a Senior Reliability Engineer specializing in Medical Devices. This position requires 10+ years' expertise in reliability for regulated hardware, especially IVD devices. We are looking for a highly experienced Senior Reliability Engineer who has a solid foundation in the Medical Device/MedTech sector.
You will be crucial in applying your skills in core reliability engineering to oversee product development, design reliability, and regulatory compliance. Your hands-on experience with tools and regulatory standards will be paramount for success. Key Responsibilities: โข Spearhead reliability engineering for IVD and regulated devices โข Carry out DFR, HALT, HASS, and accelerated life tests โข Execute DFMEA, PFMEA, and Fault Tree Analysis techniques โข Conduct Weibull analysis and life data assessments โข Design custom fixtures and lead verification testing Requirements: โข Minimum of 10 years in Medical Device/MedTech engineering โข Deep understanding of reliability engineering frameworks โข Proficient in data analysis tools like Minitab/JMP โข Working knowledge of ISO 13485, ISO 14971, and FDA regulations โข Experience in conducting various reliability tests Make a significant impact on device reliability and compliance in the Medical Device industry through your extensive expertise. #J-18808-Ljbffr