Senior Medical Device Reliability Engineer

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/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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