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: • Spearhead reliability engineering for IVD and regulated devices • Carry out DFR, HALT, HASS, and accelerated life tests • Execute DFMEA, PFMEA, and Fault Tree Analysis techniques • Conduct Weibull analysis and life data assessments • Design custom fixtures and lead verification testing Requirements: • Minimum of 10 years in Medical Device/MedTech engineering • Deep understanding of reliability engineering frameworks • Proficient in data analysis tools like Minitab/JMP • Working knowledge of ISO 13485, ISO 14971, and FDA regulations • 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