Systems Engineer Consultant II

Title: Systems Engineer Consultant II 
 Location: Carlsbad CA 
 Duration: 4 months 
 

 Description: 
 
 Essential Functions: 
 • Assess compliance gaps between the existing product specifications and the requirements in the new standards with the inputs from the Regulatory department. 
 • Perform system-level design risk analysis and provide engineering feedbacks with inputs from functional teams (e.g., uFMEA, dFMEA, SHA, Risk Matrix Analysis, etc.). 
 • Learn from and adhere to the internal quality system. 
 • Produce internal quality documentation such as risk management or design change files, matrix, specifications, test protocols, and reports. 
 • Establish effective work processes and standardized procedures that ensure compliant documentation of routine testing results and timely completion of business milestones using industry-accepted scientific principles with test laboratories. 
 
 
 Education and/or Experience: 
 • Bachelor's or Master’s Degree in an engineering discipline; mechanical engineering, materials science, or equivalent background preferred. 
 • At least 5-8 years of experience in a medical device setting. 
 • In-depth knowledge of quality assurance techniques, practices, ISO and Regulatory (FDA) compliance is preferred. 
 
 

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