Engineering Engineer

**** ******* ******

Carol Stream, IL *****

Phone: 630-***-****

************@****.***

Larry Mitcham

SUMMARY OF QUALIFICATIONS

I have twenty-five years of progressive Engineering/ Management experience with Fortune 500 companies. Solid background in Document Control, Configuration Management, FDA and, ISO practices and procedures. Software structures, FLD structures, all Document types and custom PLM reports. Effectively manages ECR/ECO process, MCO’s Deviations, change board and approval routing. Identify, create and implement BOM (Bill of Material) structures. Provide support to Engineering and Oracle user community. Trained in configuration management methodologies conforming to form, fit and function requirements when addressing revision control. Creative problem solving and multitasking abilities. Highly organized self-starter that can manage multiple projects simultaneously. Investigate, write and release ISO procedures and work instructions. Excel in providing superior services and processes of high value to internal and external customers. Excellent written and verbal communication with strong problem resolution skills. Proficient with MS product suite Excel, Word, PowerPoint, Project and Visio. Experienced working in a fast-paced environment. Dedicated and hardworking with an eye for detail. Ability to make sound judgment’s in pressured situations

PROFESSIONAL EXPERIENCE

8/2014- Present Fermilab (Contract)

Process Engineer

Provide documentation for design control, change control, design transfer and risk management

Interface with all disciplines, internal/external customers, cross functional areas and third parties.

Effectively communicate with all levels within the organization.

Comply with applicable regulations and standards for (EHS) Environmental Health and Safety, Engineering standards and other governance areas as applicable.

Comply with multiple Quality Systems

09/2012 – 8/2014 Abbott Laboratories (Contract)

QA Document Control Specialist

Review, approve and route change request

Review, approve and process change orders

Support internal/external audits in compliance with FDA and ISO practices and procedures

Administer and maintain (CAPA) Corrective Action Preventative Action

Review, maintain and file batch records

Support DSR( Design System Record) database

Ensure validation documentation is complete, filed and readily assessable for all associated organizations

Serve as SME Subject Matter Expert on database retrieval and audit preparation

Multi task across several projects while maintain strict adherence to project schedules and budget constraints

Provide high level of attention to details

04/2012-08/2012 Westell Technologies(Contract)

Documentation Coordinator

Write, review and implement work instructions for the manufacturing of telecommunication equipment

Reverse engineer multiple products

Create, document, and archive Engineering data in support of multiple Product Lines

Write, review and release Test Practices and Procedures

Provide instructional training for operational and manufacturing personnel

Established and maintain a data library

Configure, review and update BOM structures

Provide meticulously accurate data in support of Engineering, Manufacturing, Operations and Customer Support

02/2011-02/2012 Progeny (Contract)

Documentation Coordinator

Write, review and release training material on best practices in using government regulated documentation

Create operating procedures (work instructions) with photos for assembly of X-Ray machines and implemented operating procedures into assembly line.

Perform internal and external audits in compliance with FDA and ISO practices and procedures

ISO lead auditor training

Maintains DMR data across multiple products

Adherence to GMP, SOP and Lean Manufacturing Principles

Create and maintain spreadsheets to track Lean mfg. process across multiple product lines

Ensure compliance with all specifications and maintain a high level of quality

Maintain employee training records database

Create, implement and maintain (BOM’s) bill of materials on all products

Manage multiple projects while maintaining to strict requirements and budgetary constraints

Maintain online and hard copies of all Operating Procedures and Operating Schedules

Administer and maintain (CAPA) Corrective Action Preventative Action) database

Facilitate all marketing documentation review, approval routing, release process, data storage and retrieval.

Review and update changes to domestic and international manual and catalogues

ECN board coordinator run review board twice a week

QC Inspector

2008-2011 UFP Technologies

Quality Control /Shipping and Receiving

Perform incoming inspection

Maintain database for ISO practices and procedures both manufacturing and medical

Receive, address and resolve CAR’s (Corrective Action Request)

Facilitate weekly meetings addressing outstanding issues, document and follow up on pending resolutions

Hourly quality checks of manufacturing processes

Perform shipping, receiving and billing

Rockwell International 1991-2008 (Aspect and Concerto were divisions of Rockwell)

2004-08 Aspect Software Lombard IL.

Manufacturing Program Manager

Identify, write and implement Engineering Change Orders

Establish, document and maintain accurate data repository using Oracle and Agile across multiple Products

Train document control personnel on the use of Agile and Oracle

Develop process and maintain ATO (Assembly to Order) and PTO (Pick to Order) configurations.

Provide instruction support and guidance for Engineering and oracle user community.

ECR/ECN coordinator. Writes reviews and implements all engineering change orders.

Configure BOM structures in support of Sales/Marketing and Product Line

Create, maintain and ensure adherence to MS Project schedule.

Manage multiple Product Lines from conception to completion

Identify, analyze, define, and manage all engineering data

Facilitate cross-functional team meetings, generate minutes and compile reports for senior management.

Create, maintain and monitor manufacturing schedules for large projects.

Identify, obtain, and coordinate resources across multiple organizations

Establish, implement and maintain Oracle Models and Option Classes

2001-04 Concerto Software Wood Dale IL

Configuration Engineer

Provide critical custom application processes in support of CTI applications, OEM third party hardware/software and other specialized Sales/Marketing ventures.

Oracle Administrator maintaining database for operational issues

Establish, implement and maintain all configurations necessary for the installation of mainline products

Write, review, and release engineering change orders

Reviewed and ensured compliance to ISO Standards and Procedures

Created and maintained forecast using Oracle database

Control cost effective strategies which kept the department 25% below operating budget

Created cross functional matrix in support of merged companies and Product Lines which increased productivity by 25%

1999-01 Rockwell International Wood Dale IL

Manager Document Control

Manage, plan, coordinate, monitor and maintain the activities of the Document Control organization.

Coordinated, scheduled and maintain the workloads for 12 staff members

Managed ECR/ECO process for entire enterprise.

Managed Document and part number request processing.

Identify, created and implement BOM (Bill of Material) structures

Write, enhance and maintain policies and procedures as they pertain to Document Control.

Develop process documentation and work instructions.

Administrated and coordinated all activities related to establishing ISO certification

Create Doc Control templates and standards

Adhere to requirements for form, fit and function when maintaining revision controls.

Implemented cross-functional training and self-empowerment programs. This process was adopted company wide and I received “Employee of the Quarter”

Meditated between Engineering, Marketing/Sales and Product line on the completion of documentation and training manuals

Oversaw the delivery, registration and administration of all printed documentation

Established and implemented procurement procedures which meet the requirements to support the ISO initiative

Consistently coming in under budget while increase productivity

1995-99 Rockwell International Downers Grove IL

International Project Manager

Interviewed clients to assess needs and establish rapport

Prioritized and coordinated tasks to complete projects within deadlines

Developed and maintain MS Project schedules

Established and closed a deal with Eriksson which netted the company a $5 million dollar contract

1990-95 Rockwell International Downers Grove IL

OEM QA Engineer/TTL

Identified, selected, and created OEM Engineering/Quality Procedures and guidelines

Established, documented and implemented product evaluations for Hardware and Software suppliers.

Created and maintained detailed project plans for identifying all key milestones and deliverables.

Provided collateral support for installation and maintenance of released OEM products

Developed and taught training classes for installation Engineers on implementation, testing and acceptance of Computer based systems

Promote to TTL Technical Team Lead and supervised eight OEM engineers

EDUCATION

ASEE Control Data Institute of Technology Dallas TX

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