Manufacturing Engineer Medical Device
Resume:
Mark Scanlon
Hudson, NH *****
Qualification Summary -
Highly skilled manufacturing engineer with more than 30 years of experience improving profitability, quality and processes within the medical device and various other industries.
Strong understanding of New Product Introduction and Design for Manufacturing along with part fabrication techniques and GD&T.
Proven Skills -
• Design and fabrication of assembly and test fixtures • Acquisition of capital equipment (Test Chambers, Presses)
• MRP • Design for Manufacturing
• SOP’s and Routings • Acquisition of manual and automated assembly tools
• OSHA • Prototype part machining
• Acquisition of Advanced assembly tools
Teledyne Inc Chelmsford Ma. November 2015 - Disabilty
Documentation Control Support
Cogmedix Inc Worcester Ma. September 2015 - October 2015
Manufacturing Engineer
RCM Technologies Pennsaukin, NJ January 2015 - July 2015
Mechanical Technology Specialist Consultant (Assigned to Atrium Medical)
As a consultant, I am responsible for providing quality documentation support for Atriums FDA consent decree.
ControlAir Inc. Amherst, NH July 2007 – December 2014
Manufacturing Engineer
Monitor production of ControlAirs largest medical device customer (Carefusion).
Correct any part quality or assembly issues. Provide Carefusion with the required documentation (ECN’s and CAPA).
Acquired new assembly technology. (Microscopes, Loctite dispensers etc.)
Work with design staff on new product design to ensure efficient production methods.
Development of assembly and test fixtures to accommodate new products.
Set-up a small machine shop to fabricate fixture parts and small engineering prototype parts to help reduce lead times and rework costs.
Development of several semi-automated tooling designs to replace component installation by hand.
Incorporated an in-house nameplate engraving system to reduce product cost and lead-time from 6 weeks to 1 day.
Incorporated an in-house thermal label system to produce product labels. Eliminated cost of outside label source and lead-times.
Part of the Quality Audit Group. 4 of us that went to various depts and checked revisions on quality documents.
Merrimac Industrial Sales Haverhill, MA January 2006 – July 2007
Manufacturing Engineer (Temp)
Hired to coordinate efforts for new Contract Manufacturing department.
Interact with sales personnel and customers on development of custom electrical and mechanical assemblies and test fixtures.
Introduction of manufacturing standards to the manufacturing floor.
Coordinated the implementation of Cell Manufacturing.
Development of Part Numbering Systems.
Palomar Medical Inc. Burlington, MA August 1997 – November 2005
Manufacturing Engineering Supervisor
Worked directly with the Quality Dept. to ensure that FDA and ISO 13485 manufacturing guidelines were maintained.
Managed the day to day activities of 3 Senior Manufacturing Engineers.
Maintained calibration schedule for all fixtures, tools, various gauges and meters.
Sustaining engineering on Palomar’s legacy products. Replacing obsolete components etc.
Created and maintained manufacturing/process documentation for manufacturing cells.
Developed fixtures for testing and manufacturing Palomar systems and sub-assemblies.
Configuration management (BOM’s family trees and manufacturing procedures) for all new products.
Prepress Solutions February 1997 – August 1997
Senior Design Engineer
Responsible for minor designs and documentation of their new imaging product called Panther. This product transferred a computer image and etched it on to an aluminum plate. This product is widely used by magazine and newspaper publishers.
Ferrofluidics Corporation (now Ferrotec) January 1993 – August 1997
Mechanical Design Engineer
1995-1997 - Worked in the Crystal Growing Systems division creating new designs and updating old designs on their silicon growing pullers. These systems grew cylindrical silicon material later used for silicon wafers.
1993-1995 - Started at Ferrofluidics as a Design Drafting Manager/Design Engineer in the Rotary Vacuum feed though division.
My responsibilities in the design engineer portion of my position were to work with applications engineers on new rotary feed through products and work with customers on various specifications and providing them a quote on price and delivery.
Questek Inc. (Visx Massachusetts) January 1985 – February 1993
Mechanical Design Engineer
As the sole design engineer and working with scientists and upper management I was responsible for the planning, design, test and building of many new Excimer and CO2 laser products. At Questek, I had helped in producing some of the first eye surgery lasers.
GCA Corporation April 1980 – January 1985
Mechanical Designer/Drafter
Responsible for minor designs and documentation on their Wafer Stepper product.
Education/Training & Skills:
FDA Quality Systems and Design Controls
GMP training by the GMP Institute Workshop
Six Sigma Green Belt Certificate
Project Management Certificate
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