Katalyst CRO

Reliability Engineer

Danvers, MA, US

5 months ago
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Summary

Responsibilities

  • Develop and implement reliability test plans and protocols.
  • Conduct Failure Mode and Effects Analysis (FMEA) and Root Cause Analysis.
  • Perform statistical analysis and reliability data analysis.
  • Collaborate with cross-functional teams to ensure design for reliability (DfR) principles are integrated into product development.
  • Conduct accelerated life testing (ALT) and Weibull analysis.
  • Ensure compliance with regulatory standards (FDA, ISO 13485).
  • Develop and maintain reliability block diagrams (RBD) and reliability growth analysis.
  • Support corrective and preventive actions (CAPA) to address reliability issues.
  • Utilize reliability software tools (e.g., ReliaSoft, Minitab) for data analysis and reporting.
  • Provide technical support and guidance to engineering teams on reliability-related matters.

Requirements

  • Bachelor's degree in engineering (Mechanical, Electrical, Biomedical, or related field).
  • Minimum of [X] years of experience in reliability engineering, preferably in the medical device industry.
  • Strong knowledge of reliability engineering principles and methodologies.
  • Experience with reliability testing, statistical analysis, and risk management.
  • Familiarity with regulatory requirements (FDA, ISO 13485).
  • Proficiency in reliability software tools (e.g., ReliaSoft, Minitab).
  • Excellent problem-solving skills and attention to detail.
  • Strong communication and teamwork abilities.

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