Principal Reliability Engineer

What you'll do

• Write reliability plans and identify specific reliability activities to meet company and regulatory objectives.
• Perform reliability testing including HALT, ALT, and other discovery tests to identify design weaknesses.
• Support test method validation and verification by developing and approving test plans, protocols, and reports.
• Conduct reliability predictions, modeling, and data analysis to assess product risk and performance.
• Provide post-market reliability support by analyzing field performance and failure data.
• Ensure compliance with FDA requirements and international standards such as ISO/IEC 13485 and 60601.
• Lead and mentor teams in the development and maintenance of reliability processes and standards.
• Maintain accurate and compliant documentation of all reliability engineering activities, test data, and analyses.

What we're looking for

• Bachelor’s Degree in Mechanical/Electrical Engineering or Reliability Engineering with 7 years of relevant experience.
• Master’s Degree in Mechanical/Electrical Engineering or Reliability Engineering with 5 years of relevant experience.
• Experience in the medical device, automotive, or aerospace industry.
• Proficiency in quality management systems, risk management, regulatory compliance, and statistics.
• Knowledge of FDA requirements and ISO/IEC standards including 14971, 13485, 62304, FDA Part 820, and IEC 60601.
• Experience with ReliaSoft, LabVIEW, and Sherlock software (preferred).
• ASQ Certified Reliability Engineer (CRE), Six Sigma Green Belt, or AAMI design control certification (preferred).
• Work authorization at the time of hire and for the duration of employment.