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.