Sr Engineering Technician
Resume:
Marcus Goode
***********@***.***
Professional Summary
A highly talented professional with more than 10 years’ experience in the Medical Device industry and over 20 years' experience the Manufacturing environment. Comprehensive background in Inspection, Test, Validation, Process, R&D, and Quality Engineering. Working knowledge of FDA regulations, GMP, ISO13485, 6S and Six Sigma. Hands-on experience in defining validation for systems and processes with proficiency of protocols for equipment and processes. Ability to plan and organize, work effectively and provide follow-through with careful attention to detail. Proven record for productivity and complex problem resolution. Excellent communication and diagnostic skills.
Computer Skills
Proficient in Microsoft Office Suite
Lotus Notes, Outlook
Professional Experience
Beckman Coulter Inc/InfoTree, Chaska MN
Validation Test Engineer/Sr. Process Validation Test Technician 1/2017 – 5/2017
Execution of verification and validation protocols pertaining to software and instrument operation.
Automated in-vitro diagnostic instruments
Working independently as well as part of a larger multi-functional team to meet deadlines.
Document creation and revision
Process and tool validations for biomedical testing
Baxter/EXB Solutions, Brooklyn Park, MN
Validation Test Engineer/Sr. Validation Test Technician 4/2016-8/2016
Embedded software testing
Requirements Management tools (e.g. DOORS)
Configuration Management tools (e.g. SVN)
Bug Tracking tools (JIRA)
Dialysis System software test validation
Soldering (support SST/POST tests)
Review SVPs to ensure all fields are scan SVP documents into DHF
JIRAs
Create ECO forms and drive to completion
Medtronic/Wipro, Fridley, MN 8/2013-2/2015 Manufacturing Process Engineer/Quality Engineer /Sr. Process Technician
IQ, OQ, PQ, Performed processes and conducted tests from detailed instructions to characterize, verify and validate the functionality of hardware and software systems.
Prepared, set up and utilized equipment required to complete tasks as assigned.
Reviewed part drawing and specification
Working knowledge of GMP, ISO13485, 5S and Six Sigma
Updated and created component characterization and qualification protocols
Gathered component specifications from drawings
Medtronic/TechPower, Fridley, MN
Sr. Quality R&D Engineering Technician 1/2012-8/2013
Tested leads in saline solution to simulate human body temperature.
Performed destructive tinsel testing of leads using Instron test equipment
Performed processes and conducted tests from detailed instructions to characterize, verify and validate the functionality of parts, devices, hardware, software and systems
Summarized, analyzed, and provided recommendations from test results.
Identified failing conditions and confered with engineers on appropriate data collection. Suggested and assisedt with process improvements within the functional area
Prepared, set up and utilized equipment required to complete tasks as assigned
Equipment used: Instron, microscopes, calipers, soldering iron, HI-pot tester
St Jude Medical, Minnetonka, MN 8/2011-11/2011
Research and Development Process Engineer
Tested and validated manufacturing process equipment and perform operation qualifications on Catheter manufacturing.
Cleaned room equipment and summarized, analyzed, and provided recommendations from test results
Read and redlined mechanical drawings
Wrote or modified shop floor manufacturing procedures
Processed change orders (CR)
Minntech, Plymouth, MN 3/2011-8/2011
Senior Research and Development Technician
Troubleshot, tested, validated and repaired endoscopy systems software and attachments
Processed RMA's and operated basic test equipment, multimeters, power supplies, pressure and temperature measuring equipment
Documented test results on appropriate data sheets
Developed test plans, and test sequences to collect pertinent performance data
3M, St. Paul, MN 6/2010-3/2011
Sr. Research and Development Laboratory Technician
Assisted in laboratory experiments through development, testing, and evaluation of new materials and products based on research
Performed tensile and fatigue testing using INSTRON machine using Bluehill software
Maintained accurate client reports and accelerated aging and shelf life testing on 3M products
Coloplast, Minneapolis, MN 6/2007-4/2009
Research and Development Technician II
Designed test fixtures and prototypes with engineers
Operated, maintained and calibrated laboratory equipment and measuring dimensions of parts
Drafted technical documentation including test results, procedures, and first article inspection
Designed and fabricated basic tooling fixtures
Validated test methods and provided recommendations
Accelerated aging and shelf life testing
Designed and coordinated basic engineering tests and experiments using Solidworks
DVT, Tensile, fatigue and compression testing using INSTRON tester
SOLIDWORKS file editing for a STRATASYS DIMENSION 3D printer
Responsible for heat treat and form Nitinol for prototype assemblies
IQOQ for installing and moving and equipment
Provided IT Support, upgrades and imaging for all lab computers
Acist Medical Systems (Bracco), Eden Prairie, MN 11/2005-6/2007 Manufacturing Final Test Technician
Working knowledge of GMP, ISO 13485, ISO 9000,9001, 5S and Six Sigma
Inspected, built, tested, calibrated and verified assemblies for contrast injection systems and final products
Validated manufacturing and test procedures, prints and BOMs
Performed online transactions with MRP/ERP system
Identified and implemented improvements in order to meet production goals
Verified work complies with FDA, ESD and ISO 13485 guidelines
Performed tests using oscilloscopes to verify operation
Proficient experience with computer entry such as MAX, Lotus Notes, MS Excel
American TeleCare, Eden Prairie, MN 4/2002-9/2005 Supervisor/Quality Control/Manufacturing Technician
Supervised manufacturing employees and trained on new and updated processes
Executed software tests (manual and automated) and recorded results (Excel spreadsheets)
Managed repair department and provided repair quotes and time estimates on and off the phone
Troubleshot computers and Telehealth systems; tested and validated software
Repaired, tested and processed customer return authorizations (RMAs) in MAX, Excel and Word
Identified and troubleshot process, material or equipment problems to create a steady work flow
Configured computers to be compatible with Telehealth monitors and customer’s network
Installed and managed the new electronic static device control system (ESD)
Provided first article inspection compared against drawings and blueprints using micrometers, calipers and pin gauges
Verified work complies with FDA, ESD and ISO 13485 guidelines
Education
HS-Winnetka LC
ITT Technical Institute
BS-Network Systems Administration Expected Graduation 2018
Certifications
SolidWorks Essentials 2007 Certification
Visual Management & 6S Certification
Solder Training Certification
Process and Print Reading Certification, ESD Certification
Electronics Certification
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