Summary
Overview
Work History
Education
Skills
Timeline

MARIA F. GONZALEZ

MIAMI,FL

Summary

Dynamic Engineer with 12 years of experience in the Medical Device Industry with great knowledge of process change documentation and root cause analysis. Proven track record of optimizing operations, new product transfer and launch, enhancing efficiency. Organized and dependable candidate successful at managing multiple priorities.

Overview

12
12
years of professional experience
2
2
Languages

Work History

Principal Operations Engineer

InNeuroCo
09.2019 - Current
  • Operations lead of new product Balloon Catheter transfer from Design to manufacturing.
  • Responsible for builds required for Design Validation and Verification activities, resolution from Design observations, development of manufacturing processes and documentation, process characterization and validation, execution of Test Method Validation and pFMEA
  • Improved operational efficiency by streamlining processes and by continuous process improvements
  • Improved product quality by implementing robust testing procedures and updating manufacturing processes.
  • Cross-functional technical review for 510K submissions of new products
  • Streamlined production lines for increased efficiency, reducing defects and minimizing waste.
  • Supported questions from FDA for 510K submission, created impact assessments and provided evidence needed for response to regulatory agency
  • Served as liaison between engineering, manufacturing, and customers to address concerns regarding product quality or performance issues.
  • Project lead of new configuration of released device to include accessories and new packaging as result of device users feedback
  • Collaborated with cross-functional teams to optimize design, manufacturing, and validation processes to ensure seamless integration of new products.
  • Conduct root cause analysis, risk assessments, and incident investigations
  • Optimized inspection methods for decreased downtime while maintaining strict adherence to quality requirements.
  • Develop and validate (IQ, OQ, PQ) manufacturing process for medical devices (Ex: catheters, introducers, microcatheters, balloon catheters, etc.) Managing initial manufacturing pilot builds of new products and managing cost reduction and productivity improvement projects
  • Troubleshot complex issues under tight deadlines, prioritizing tasks effectively to minimize disruptions to ongoing operations
  • Provided Quality department support with non-conformance investigations and CAPAs Supporting and improving manufacture and performance of existing products
  • Responsible for generating and maintaining all documentation related to process development, including, but not limited to engineering studies, process verification protocols and reports, process FMEA, manufacturing instructions and routers.
  • Mentored entry and junior level manufacturing engineers and conducted training sessions on responsibilities, medical industry GM practice and product validations
  • Monitored and optimized production processes to increase throughput and improve quality
  • Lead transfer of Molding Equipment and processes to new facility building
  • Responsible for generating impact assessment of equipment move, validation master plan, validation/verification protocols, executing testing and analysis of results as well as meeting customer requirements.
  • Analyzed and interpreted data to identify trends and recommend improvements.

Senior Manufacturing Operations Engineer

Codman Neurovascular, Johnson & Johnson
06.2012 - 09.2019
  • Collaborated and contribute to successful audits during internal/external Quality, and Engineering Audits including FDA and BSI
  • Lead Engineer for several production lines to maintain high performance on each operation
  • Troubleshoot, diagnose issues and develop FMEA/root cause failure testing utilizing Failure Modes & Effects Analysis in Balloon Catheter
  • Lead Engineer for two process transfer from Fremont, CA to Miramar, FL
  • Activities included creating procedures, training operators, validation of process and equipment, logistics to initiate production of new processes
  • Negotiate with suppliers to obtain competitive quotes, determine most effective equipment, and ensure timely delivery and installation of products
  • Monitored multi-site CA and FL capital budget as well as savings obtained from Cost Improvements site projects (CIPs)
  • Held monthly meetings and reported to higher management monthly forecast
  • Developed and executed validation protocols (IQ, OQ, PQ) and reports for various processes
  • Conduct root cause analysis, risk assessments, and incident investigations
  • Analyze and implement improvements and corrective actions
  • Lead investigation for audit observations and execution of actions and monitoring period
  • Contribute to Lean Manufacturing implementation for production line, by assessing equipment capability, introducing innovative solutions to implement one direction manufacturing flow system, analyze current cycle time and identify non-value added vs Value-added steps
  • Lean project resulted in savings of $150K
  • Completed process characterization studies (DOEs) and generated various technical reports
  • Successfully supervised work of technicians and others who assisted in specific assignments, in order to achieve corporate derived goals and objectives in timely manner
  • Lead and/or participates in process improvement initiatives, including six sigma activities necessary to achieve team objectives
  • Support implementation of new calibration and preventive maintenance system
  • Analyze validation test data by means of six-sigma process improvement methods to determine if process met validation criteria and is capable of producing sustainable good units
  • Responsible for entering data into Enterprise Resourcing Planning (ERP) System for traceability and count accuracy of material and catalog units with assigned lot numbers
  • Manage material inventory control project to improve traceability, usage ratio and accuracy with yearly savings of $80K
  • Leading continuous efforts for reduction of non-conformances in Materials department.

Education

Bachelor of Science - Biomedical Engineering

Florida International University, Miami, FL
05.2012

Skills

  • Six-Sigma Green Belt Certification
  • Minitab
  • Process/Equipment Validation (IQ, OQ, PQ)
  • Product and Process Transfer
  • Root Cause Analysis
  • Lean Manufacturing
  • Design of experiments
  • Manufacturing operations
  • Cross-Functional Teamwork
  • Workflow Optimization
  • Testing Methods

Timeline

Principal Operations Engineer - InNeuroCo
09.2019 - Current
Senior Manufacturing Operations Engineer - Codman Neurovascular, Johnson & Johnson
06.2012 - 09.2019
Florida International University - Bachelor of Science, Biomedical Engineering

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MARIA F. GONZALEZ