SUMMARY

• Improve Testing | Reduce Errors | Meet Compliance | Decrease Failures | Enhance Design DeliveryLeveraging hands - on comprehensive experience developing creative ways to solve complex problems, utilizing strong mathematical, statistical, and workflow analysis skills.
• Energetic and results driven with proven success in working with global cross-functional teams to achieve outstanding results. Known for consistency in achieving optimal utilization of production equipment through process improvement, project coordination, and cultivating of strong technical relationships. Possess in-depth knowledge and understanding of blueprints, mechanical drawings, and electronic schematics.
• Equipment Troubleshooting | Process Engineering | Technical Training | Lean Manufacturing

TECHNICAL SKILLS

• Proven track record of troubleshooting electronic and mechanical systems to component level
• Experienced with electronic test equipment: Oscilloscope, DMM, Spectrum Analyzer, Digital Logic Probe
• Experienced in Lean Manufacturing
• Extensive experience in Safety & Quality leadership
• Skilled trainer/training coordinator
• Experience with Computerized Maintenance Management (CMM) Systems
• New York University, M.S. Management & Systems
• Experience with FDA, GMP, Part 820, CE, ISO 13485 Medical Device Standards, ISO 9001
• Excellent communication and presentation skills
• Experienced in cGMP and Clean Room environments
• Proficient with Trackwise and Diadoc, Quality and Change Management software

PROFESSIONAL EXPERIENCE

Confidential, Littleton, MA

Senior Manufacturing Engineer / Contract w Bentley Global

Responsibilities:

• Develop, maintain and improve procedures, documentation, tools, fixtures, and programs on electro-mechanical assemblies, and final products.
• Identify the root cause of manufacturing process and product nonconformities. Identify and implement the necessary actions to correct and prevent recurrence though the corrective and preventative action process.
• Work in conjunction with Product Development engineering in the creation of processes and procedures, including test programs to verify the performance to specification of new assemblies, peripherals, and products
• Initiates and/or approves all necessary changes in design, drafting, tooling, methods, processes and any documentation that affects the manufacturability of an item or process.

Confidential, Marlborough, MA

Manufacturing Engineer

Responsibilities:

• Improved testing requirements and reduced errors by developing new processes and testing procedures for the cobas® Liat® Analyzer, compact PCR system.
• Reduced integration failures by overseeing troubleshooting of electromechanical and optical subassemblies to component level.
• Supported manufacturing, process development, and product research efforts by collecting data and performing statistical analysis.
• Improved problem resolution time by correcting electromechanical integration failures and documenting findings in technical database for later reference.
• Eliminated documentation ambiguity by creating and revising manufacturing assembly and testing work instructions, including visual aids, specifications, SOP’s, and technical documentation.
• Investigated manufacturing related failures, process deviations and complaints by identifying trends and performing root cause analysis.
• Met and supported Quality System Compliance and improved manufacturing efficiency by participating in Non-Conforming Instrument Investigations (QAR’s) and implementing Corrective and Preventative Action (CAPA) activities.
• Enhanced technical comprehension of technicians by creating technical training presentations.
• Verified new product software upgrades by checking and verifying equipment functionality and accuracy.

Confidential

Manufacturing Engineering Specialist

Responsibilities:

• Monitored all engineering practices and resolved inefficiencies by reviewing process related data and comparing to expected operational parameters and control limits.
• Enhanced efficiency by performing operational test and fault isolation on systems and equipment.
• Improved quality by identifying process related issues and implementing corrective actions.
• Resolved technical issues found within manufacturing by identifying bottlenecks and applying Lean Manufacturing techniques to improve line throughput.
• Reduced overall manufacturing costs by applying Lean Manufacturing methodologies to equipment maintenance and repair, completing Intel sponsored Lean Training.

Test Engineer

Confidential

Responsibilities:

• Achieved quality goals by performing data analysis and providing recommendations.
• Supported ongoing production test needs through troubleshooting and technical support of equipment related issues.
• Ensured proper identification of microprocessor related failures by collecting and recording testing data and identifying nonconforming test.
• Verified new design functionality and identified areas for improvement by collecting, analyzing, and communicating test results to project engineers and stakeholders.

Senior Equipment Technician

Confidential

Responsibilities:

• Reduced equipment downtime and improved production line output by troubleshooting and repairing electromechanical problems on automated high technology manufacturing equipment.
• Improved manufacturing capability by preparing technical documentation for equipment upgrades and modifications.
• Improved equipment utilization by troubleshooting nonstandard events in the production line, and reviewing statistical process control (SPC) data for process stability and quality control.
• Corrected documentation deficiencies and maintained more effective manufacturing environment by improving instructions and revising existing procedures.
• Met compliance by managing training requirements and certification deadlines for fifteen technicians.