Mike

2/25/2014
Unknown

Position Desired

Quality Engineering
Manchester, NH
Yes

Resume

EDUCATION

WENTWORTH INSTITUTE OF TECHNOLOGY, Boston, MA
Bachelor of Science in Mechanical Engineering Technology
Cumulative GPA: 3.3


TECHNICAL COMPETENCIES

Engineering: Instron Universal Testing Machine, Strength Testing, Strain Gauges, Welding, Machining,
Design: Mechanical Graphics, Mechanical Design I & II, Mechanical CAD Applications I & II
Information Technology: Solidworks, AutoCAD, Mechanical Desktop 6, Working Model 2D, Crystal Reports,
Manufacturing Technology: Statistical Analysis (MiniTab), Programming Vision System and CMM


PROFESSIONAL EXPERIENCE

Davol, a Subsidiary of CR Bard, Warwick, RI, January 2008 – Present, Advanced Quality Engineer
Davol is the market leader in comprehensive soft tissue reconstruction, delivering trusted products and techniques for hernia repair, specializing in surgical procedures, fixation and biologic implants.

• Designing unique gages for complex geometry and measurement of highly critical components
• Aiding in the creation of Product Performance Specifications (PPS) and testing for effectiveness
• Creating design and process documentation such as Design Failure Modes and Effects Analysis (DFMEA), Process Failure Modes and Effects Analysis (PFMEA)
• Working with New Product Development and Marketing in creating Design Input Specifications for new devices and extensions
• Aiding in the creation of Design Verification, Clinical and Non-Clinical Design Validations
• Performing Tolerance Analysis for critical functioning components and interactions
• Developing Test Methods and measurement techniques in order to adequately measure components, sub assemblies and finished devices
• Driving Quality objectives through internal and external suppliers
• Aiding in the creation of the procedures and work instructions in compliance with FDA CFR requirements and guidelines
• Writing detailed instructions and reports for project review
• Writing Lab protocols for determining shelf life of particular biologics and polymers
• Creating Inspection Plans for Incoming and In Process inspection
• Coordinating Gage R&R’s for critical to function components
• Investing in the latest technology in order to achieve launch dates of products
• Writing protocols and reports for Design of Experiments
• Writing Protocols and Reports for Installation Qualification, Operational Qualification and Performance Qualification (IQ, OQ & PQ)
• Analyzing critical to process data in determining process capability and process variance
• Programming CMM’s and Multisensor Systems for use
• Training of operators in various tasks from incoming inspection to machine operation



MicroGroup, Medway, MA, November 2004 – January 2008, Quality Engineer
MicroGroup, Inc. is recognized as a leading supplier of precision manufacturing services, stainless steel and nickel alloy tubing, fittings, valves and unique tools.

• Creating Control Plans
• Writing PFMEA for critical parts
• Writing Validation Protocols for special processes such as Laser Welding
• Implementing and Aiding in the performance of IQ / OQ / PQ for tooling and processes
• Handling complaints and corrective action requests internally and externally
• Helping in creation of inspection plans on new QC equipment.
• Investigating and responding to Internal and External Corrective Actions
• Designing intricate gages for inspection on complex geometry products
• Implementing new Quality System
• Coordinating Gage R&R’s along with capability for Critical Processes and Products
• Performing random Gage Audits
• Coordinating Devices for calibration with outside services
• Maintaining Calibration System
• Programming OGP Vision System
• Serving on committees as well as various process improvement teams and quality circles
• Training emp...

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