SUMMARY

• 20+ years hand - on experience providing production support in multiple industries, performing data analysis, documentation management, tooling & fixture design, SPC and project management
• 3+ years of experience using AutoCAD and possess good knowledge of Solidworks
• 15+ years of experience managing QMS. Performed failure analysis on field returns to determine root cause of problem and improved product quality
• 15+ years of experience managing Vendors/Suppliers working closely to eliminate root cause of discrepant material
• 5 years of experience working for Medical Devices Industry

• Mechanical Problem Solving, Continuous Improvement, Root Cause/Statistical Analysis, IQ & PC
• Hands-on Production Support, Documenting/Optimizing Complex Procedures & Inspection Methods
• MS Office Suite, Project, Minitab, Lotus Notes, AutoCAD, SolidWorks, Oracle, SAP & Agile
• Honest, diligent, self-directed, effective communicator focused on success of the mission

PROFESSIONAL EXPERIENCE

Confidential, Merrimack, NH

Senior Manufacturing Engineer

Responsibilities:

• Provided hands-on manufacturing engineering support for balloon expandable covered stent
• Worked closely with Engineering to create & implement production equipment, tools and fixtures
• Updated detailed process instructions, as required, to reflect current build procedures
• Used MS Excel and analyze data to determine trends in the manufacturing process
• Lead scrap reduction project to reduce the cost of quality” and backlog orders
• Prepared and submitted DCOs & ECOs using Agile PLM system
• Created, updated and implemented installation qualification (IQ) protocols and reports

Confidential, Danvers, MA

Senior Manufacturing Engineer

Responsibilities:

• Created and implemented documentation required for IQs & process characterization
• Used precision measuring equipment to measure and verify critical dimensions
• Worked closely with Engineering to create & implement production equipment, tools and fixtures
• Performed root cause analysis on discrepant (NCMR) product returned for evaluation
• Originated change orders using Agile to update and release all types of documents
• Captured high resolution/magnification images using precision optical measuring equipment
• Provided classic hands-on manufacturing engineering support for multiple product lines

Confidential, Merrimack, NH

Quality Engineer

Responsibilities:

• Created and incorporated QC Check instructions into process instructions for entire product line
• Resolved technical issues with product, process and documentation
• Liaison between Engineering and Manufacturing ensuring documentation was accurate & complete
• Collected, analyzed summarized and published product failure data

Confidential, Billerica, MA

Quality Manager / Engineer

Responsibilities:

• Determined process settings required to make custom sized aerogel compression packs
• Dispositioned defective material and ensured product meets inspection & test plan requirements
• Assisted third party auditors with on-site inspection and monitoring services
• Managed site calibration program and the daily activities of (2) Quality Control Technicians
• Collected, analyzed and summarized data in countless spreadsheets used to manage the process
• Implemented high resolution camera measurement system as integral part of new SPC program

Confidential, Chelmsford, MA

Senior Manufacturing Engineer

Responsibilities:

• Provided hands-on manufacturing support for atmospheric robot production
• Dispositioned defective material and worked closely with SQE to resolve issues with product quality
• Design & implement tooling to increase productivity and enhance operator safety
• Provided mechanical inspection services to verify compliance to precision specifications
• Performed failure analysis to determine root cause of problem and improve product quality

Confidential, Peabody, MA

Senior Manufacturing Engineer

Responsibilities:

• Implemented upgrades the TSA certified COBRA X-Ray baggage screening system
• Created process documentation related to upgrade from single to dual use scanner
• Ensured that all Engineering documentation was correct and complete and modified, as required

Confidential, Tewksbury, MA

Lead Manufacturing Engineer

Responsibilities:

• Provided mechanical expertise for modular fabrication & assembly of a prototype CIGS glass tool
• Created test requirements for contract manufacturers to develop their Factory Acceptance Test
• Established a Manufacturing Requirements that defined responsibilities for each functional area
• Facilitated brainstorming meetings to enhance all aspects of project cost & manufacturability
• Worked with Design Engineering to create & release new part specifications and Bills of Materials
• Performed supplier evaluations using a standardized report format that I created
• Worked with Master Planner to ensure proper HTS & ECCN codes for items being ex-ported
• Reviewed complex drawings to ensure compliance with design & production requirements
• Worked with Solid Works models to extract various information needed for a variety of purposes
• Prepared a comprehensive plan to dismantle, move & restart our prototype vapor deposition tool
• Worked w/global supply chain to identify components that could easily be sourced in Europe & Asia
• Developed a “Merge-in-Transit” plan to ship complex pre-tested modules directly to customer sites

Confidential, Burlington, MA

Quality Manager

Responsibilities:

• Managed team of 8 technicians, Incoming, In-Process, Final Inspection & Functional Testing
• Managed the Corrective/Preventive Action processes and UL Follow-Up Inspections
• Managed Control of Documents & Records for the Quality Management System
• Managed performance acceptance testing and tracked 1st pass yields with Pareto analysis
• Managed the calibration program for multiple US locations
• Conducted quarterly management review meetings with senior management
• Inspected wide range of sheet metal, precision machined and electronic assemblies
• Participated heavily in new product introductions & pilot run activities
• Resolved all discrepant material issues (DMRs) working directly with suppliers
• Managed all internal audits & audit reports as Lead Auditor and documented supplier evaluations

Confidential, Wilmington, MA

Manufacturing Engineer

Responsibilities:

• Provided hands-on support for production of ozone generators built in clean room environment
• Determined disposition of nonconforming material, (NCMRs)
• Created, evaluated, approved & rejected ECOs to all types of controlled documents
• Created/updated complex work instructions in compliance with “Copy Exact” protocol
• Designed, modified, improved tooling/fixtures & justified capital equipment
• Used statistical analysis techniques to optimize epoxy performance
• Worked closely with many suppliers to eliminate root cause of discrepant material

Confidential, Andover, MA

Manufacturing / Quality Engineer

Responsibilities:

• Project Manager for outsourcing and validation of the S&N TriVex Illuminators
• Performed DOE to validate a soldering process as alternate method for brazing sapphire to metal
• Provided hands-on support for endoscope production in heavily regulated environment
• Determined dispositions of discrepant material as part of Material Review Board
• Performed product/process testing, inspection and DOE per ISO 13485 QMS
• Identified and documented machining procedures for product rework and salvage
• Coordinated repair and calibration of production equipment used to make endoscopes