SUMMARY:

I am an experienced Manufacturing Engineer/Project Manager with the unique ability to combine hands - on fabrication and assembly experiences with Lean 6-sigma quality improvement techniques. My project, engineering, and Quality Control responsibilities reflect a strong understanding of business objectives, detailed knowledge of world class manufacturing practices, and team building leadership. I’ve been highly successful at implementing new manufacturing processes, new equipment, and new technologies.

PROFESSIONAL EXPERIENCE:

Confidential, St. Louis, Missouri

Project Manager/Quality Control Supervisor

Responsibilities:

• Coordinate capital equipment projects through purchasing, validation, and implementation into production.
• Provided shop floor layout and technical specifications for building a new class 8 clean room, validated all of the clean room production equipment, wrote all clean room SOPs, and trained employees on all procedures.
• Implements packaging equipment for new sterile products which were vacuum sealed in 100% oxygen.
• Wrote training plan and conducted total plant training on the basics of cGMP for all employees and management staff.
• Supervise the QC department in daily inspections, calibrations, validations, and permanent record maintenance.
• Develop and write manufacturing procedures (SOP) and process documentation for manufacturing and Quality Control.
• Coordinate and implemented new business (acquisitions & new products) into production.
• Tear Mender (Business acquisition)
• Quake Kare (Business acquisition)
• OxyBand (Proprietary medical device)

Director - New Business Development

Confidential

Responsibilities:

• Develop new business opportunities that fit the facility, equipment, and mission for providing blind employment at two Confidential Industries plants in St. Louis (a non-profit, AbilityOne certified business).
• Coordinated a 17,000 sq. ft. building expansion that included construction of a Class 8 clean room and the implementation and validation of an automated Multivac R-145 Form-Fill-Seal machine.

Confidential, Bridgeton, Missouri

President / Principal Manufacturing Engineer

Responsibilities:

• Provided project management, validation leadership and Quality engineering for Confidential compliance for new and existing manufacturing processes.
• Project manager for the implementation of a new product (oxygen enriched dressings) and the new manufacturing processes to produce it.
• Developed business case justifications for new products and equipment. Responsible for implementation of Lean 6-Sigma procedures for manufacturing.
• Implemented new production practices adapting automated packaging equipment for blind and visually impaired work force personnel. Designed and implemented “tool-less” changeover processes, new fixturing, and tooling for the blind. Wrote detailed Work Instructions, Confidential medical compliant equipment validation protocols, and quality documentation (SOP, Process Flow, Manufacturing and Safety Procedures, FMEA, and Equipment validations).
• Covidien/Mallinckrodt Pharmaceuticals (Aerotek). Provided Research & Development (R&D) Engineering support for new and existing products and manufacturing support. Designed and developed test protocols, validation processes, and new product research.
• Provided advanced Manufacturing Engineering concepts for improving production of Bipolar Forceps.
• Developed improved Polyvinyl coating process and designed and implemented assembly tooling for improving final assemble cycle times.
• Assisted resident manufacturing engineers with manufacturing issues in various value streams as needed.
• Livingston Tool & Manufacturing Company. Project manager for relocating the complete Confidential machining and Injection Molding facility to a new building.
• Responsibilities included plant and equipment layouts (cellular arrangement), planning machine move sequencing, and coordinating electrical contractors and production schedule requirements for uninterrupted customer service.

Confidential, St. Louis, Missouri

Project Manager / Senior Manufacturing Process Engineering / Validation Engineer

Responsibilities:

• Manufacturing Engineering Leader for new and existing surgical packs production. Initiate and implement manufacturing process improvements and resolve manufacturing problems using Lean / 6-Sigma data analysis techniques.
• Created all Quality Validation Protocols and conducted the validation analysis for new automated processes, packaging, and safe work practices in the packaging areas.
• Develop business case justifications, Time line (MS Project) and implement new manufacturing products and processes.
• Coordinated fabrication and design with outside vendors (foreign and domestic) for specialized packaging and assembly machines
• Project Manager for capital equipment and process improvements and new automated equipment.

Confidential, St. Louis, Missouri

Senior Technical Specialist / Strategic Modernization Leader / Process Engineer

Responsibilities:

• Process Engineering Leader for manufacturing technologies and facility modification projects in metal fabrication and composites manufacturing areas.
• Project Manager for new process improvements
• Purchase and implemented three (3) new High-Speed Confidential Machining Profilers

Confidential, St. Louis, Missouri

Project Manager

Responsibilities:

• Project Manager on Rotary Transfer Line equipment proposals for Confidential and Confidential to assure their machining specifications, performance requirements, and 6-sigma quality requirements were met or exceeded.