Senior medical device reliability engineer
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We are looking for a highly experienced Senior Reliability Engineer who has a solid foundation in the Medical Device/Med Tech 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/Med Tech 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.
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