OBJECTIVE

I am looking for a position that is the right fit. I bring a diverse background and skillset to the table with strong manufacturing and operations skills. I am well versed in practical problem solving, backed by a Six Sigma Green Belt. I am looking to find a position to constantly improve myself and others around me by challenging everyone to be better.

WORK EXPERIENCE

Manufacturing Manager – 2014 -Present

OxySure Systems – Frisco, TX

Manage manufacturing and operations activities for a medical device manufacturer. Manage assemblers in the assembly of devices. Control purchasing and inventory levels.

Ensure continued compliance with FDA GMP’s and train staff as necessary. Support engineering and regulatory staff in ongoing projects.

Construction Superintendent – 2012- 2014

Medlink Development

Manage commercial construction remodel projects, interfacing with architects, MEP engineers, and subcontractors. Perform basic remodel finish out tasks, including paint, drywall, flooring, etc.

Manage removal and installation of capital medical equipment, utilizing install/deinstall engineers, transport companies, and equipment rigging companies.

Manager - Technical Support and Service - April 2009 - 2014

Phi Health/ Vannevar Group - Richardson, TX

Computer Software

Provide customer centric phone, online, and on-site support for medical diagnostic software. Install and train software at client locations.

Helped implement new medical software product to market. Responsible for installation and customer training on customizable software. Interface with institutional IT staff to configure user permissions and settings for each site. Troubleshoot and configure PACS communications at client locations.

Developed and recorded on-line and computer based software and education training materials, using software capture technology.

Provide phone and on-line customer support for medical software, using WebEx and other remote access software.

Log and monitor progress on software bugs. Upgrade client sites with new revisions of software as required.

Manufacturing Manager - May 1995 - March 2009

Chase Medical Richardson, TX

Production Responsibilities:

Managed up to 50 employees in team structures.

Used continuous process improvement.

Ensured compliance to FDA Code of Federal Regulations, ISO 9001, EN46001, CE marking, ISO 13485.

Responsible for hiring, performance review/counseling, production scheduling.

Familiar with material handling and warehouse controls.

Intimate knowledge of product and component traceability.

Responsible for creation of work instructions and technical procedures as

required.

Created BOM's, general SOPs, and quality specifications.

Created modular training program for all hourly employees

Process Revalidation on multiple production processes

Managed Inventory Control, Purchasing, Material and Production planning, Maintenance and Calibration program

Engineering responsibilities (concurrent with Manufacturing):

Familiar with receiving inspections. Communicate and negotiate with suppliers for quality and delivery issues. Improve design concept into repeatedly manufacturable product. Product and process improvement. Intimate knowledge of various bonding methods: Solvents, UV cure. Managed plastisol dipping development, implementation, and manufacturing using hot-dip molding. Assisted in development of solvent based dip molding and managed production of dip molded subassemblies.

EDUCATION

Bachelor's Degree, May 1998 University of Texas at Dallas

-Received BA in Interdisciplinary Studies - Focus on Management of Medical Issues

-Combined Management curriculum with a solid grounding in the hard sciences, especially Biology

SKILLSETS

General Management

Product and Process Validations

Six Sigma Green Belt

Regulatory compliance – FDA CFR 820, ISO 9001, ISO 13485, EN 46001

Inventory Control

Training

ERP/MRP systems

Cardiac and General anatomy and function

Technical Support

MRI design, operation, and maintenance

Medical device assembly methods

Lean Manufacturing

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