James Eagle Email & Phone Number

Tewksbury, Massachusetts, United States

Needham, Massachusetts, United States

Woburn, MA

Greater Boston Area

Bedford, MA

• Analyzed executed batch records to tabulate and plot in-process and batch release data. Performed trendanalysis and process monitoring.
• Performed experiments and presented data to evaluate and identify process bottlenecks and inefficiencies
• Developed programs to calibrate and measure parts using an industrial machine vision systems
• Performed particle identity testing using Scanning Electron Microscopy (SEM) for the purpose of correlating identity with particle Optical Microscopy (OM) appearance.
• Supported activities for New Drug Application (NDA) submission and FDA Prior Approval Inspection (PAI) readiness including conducting investigations and executing engineering protocol builds.

Lawrence, MA

• Assisted in Risk Analysis including, Fault Tree Analysis (FTA), Operator Misuse Analysis (OMA), and FailureMode and Effects Analysis (FMEA) activities
• Worked with Quality Assurance and Research and Development to maintain an approved internal Quality System that meets the requirements of GMP’s, QSR and ISO 9001.
• Debugged new designs and developed improvements to existing & new design using SolidWorks
• Provide technical support for product engineering, design development, integration, test and evaluation

Billerica, MA

• Designed and documented manufacturing fixtures using SolidWorks
• Developed and executed validation and verification protocols
• Generated engineering change orders to maintain compliance with FDA and ISO 13485 standards
• Collaborated with a team to implement “5S” program for manufacturing efficiency, specific responsibilities included analysis and reorganization of technician work spaces

Bachelor'S Degree, Mechanical Engineering

Advanced Governor’S High School Diploma