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Katalyst CRO

Reliability Engineer

Katalyst CRO, Danvers, Massachusetts, us, 01923

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Katalyst CRO 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.

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. Seniority level

Seniority level Mid-Senior level Employment type

Employment type Contract Job function

Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Reliability Engineer” roles.

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