Medical Device A Manager

JAMES I. WHITE ***** N. Harbourside dr

Fort Wayne, IN 46814

Cell: 224-***-**** EXPERIENCE E-mail: *********@*****.***

Avalign Technologies I&I / LLC. Fort Wayne, In 9/22-10/24

NPI Senior Manufacturing Engineer II

Works with representatives from customer service, manufacturing, quality assurance, scheduling, and purchasing in developing and coordinating new project development, sustaining products, suppliers, and internal operations.

oAct as customer liaison on new and legacy projects

oCreate project quotes

Create costing of product

Apply margins in adherence to corporate goals

New Projects

oAct as project manager for new projects to ensure quality and on time delivery

oInitiate and coordinate preproduction meetings w/ customers and internally.

oCreate device master record (DMR) / processes that meet and/or exceed product, Avalign, ISO, FDA, and customer specifications and requirements

oPerform design for Manufacturing/Cost/Quality - Technically support customer to eliminate costs and maximize delivery of product.

Post Productions – Initiate and complete

NCMR – disposition of product to meet Avalign and customer specifications

Continuous improvements in all areas of the facility

Support quality, operations, and purchasing groups

Decision making supportive of Corporate goals and Standards

Develop Expectations that need to be met by the quoted OEE Standards, set up metrics to tell if winning overall %

Dana Corp / AAM. Bluffton / Fort Wayne 9/16-7/2022

Manufacturing Engineer Lead

Responsible for writing all procedures of operation, and validation of Equipment within the plant for the company’s quality manual, per TS16949 and ISO9001.

Responsible for the purchasing and implementation of new equipment and materials.

Responsible for the engineering of new projects, including fixturing and tooling for Optimal cycle times for quoted parts per hour.

Automation projects that include Fanuc and ABB Robots as well as Siemens and Rockwell PLC’s

Development of design standards and design controls for internal and outsource process.

Responsible for the design of all new mold cavities for manufacturing and corresponding

procedures.

Development of all new cell layout and special tooling on SolidWorks and Autocad CAD System.

LEAN and CI role model / leader.

Responsible for concept of special designed on fixtures and cutters, also combination of cutting tools with 25% cycle time savings.

Manage NPD (New Product Development) projects. Ensure to hold 1.33 Cpk on all critical dimension. Create new CNC Programs and Tool Set-up sheets.

Collaborate with developers, Integrators, Process Engineers, project managers, and maintenance to understand the requirements and scope of the projects at the Drive Shaft Processing Department a Heavy Automated area

Recommends, develops, and implements enhancements and improvements to increase production volume or precision in high throughput operations

Assist with cost estimates and project calculations for anything at the Drive Shaft Processing Center

Lead the operational leaders at the Drive Shaft Processing Department by developing strategies to reach the success 90% OEE

TTI (Techtronic Industry) Donggaun China 11/15 - 06/16

Advance Manufacturing Engineering Manager

Acts as a liaison with engineering in releasing new products. Develops systems to maintain reports and record keeping of company products, CNC programs and set-up sheets.

Selects, develops, and evaluates personnel to ensure the efficient operation.

Developing and reporting resolution schedules to the operations and senior management staff.

Interfaces with project and design engineering in the coordination of activities necessary for the release of new products.

Estimates manufacturing costs determines time standards and makes recommendations for tooling and process requirements for new or existing product lines.

Works on unusually complex, sensitive and unique problems and provides state-of-the-art solutions that are highly creative. As an expert in the field, utilizes professional concepts and principles to develop solutions to critical issues and broad production matters.

LEAN and CI role model / leader.

Managed group of eight Engineer’s with detailed technical training, training MGF operators, distributors and manufacturing quality personnel on all CNC productions equipment and checking methods.

Manage NPD (New Product Development) projects. Ensure to hold 1.33 Cpk on all critical dimension on all medical devise production.

Managed group of five Design Engineer’s for fixtures and detailing part prints. Also technical training on CNC productions equipment and checking methods to Ensure Cpk of 1.33.

Responsible for quality and manufacturing engineering support.

Implemented methods to decrease set-up time by 80% using SMED techniques and placing most set-up items in one common place.

Ensure all casting are free from porosity and voids. Traveled to tool makers to make any necessary adjustment to the die mold gating and ensure an acceptable part.

HN Precision Lake Bluff, IL 03/14-11/15

Manufacturing Engineering Manager & Training Engineer

Managed and reporting resolution schedules to the operations and senior management staff.

Estimates manufacturing costs determines time standards and makes recommendations for tooling and process requirements for new or existing product lines concerning medical devices.

As an expert in the field, utilizes professional concepts and principles to develop solutions to critical issues and broad production matters.

LEAN and CI role model / leader.

Managed group of eight Engineer’s with detailed technical training, training MGF operators, distributors and manufacturing quality personnel on all CNC productions equipment and checking methods.

Manage and Established new machining processes and identified requirements necessary to take a product from research and development to production through PPAP submission and APQP.

Responsible for the production flow of the machining base and saving 15% of flow reduction.

Manage and implemented quality control to reduce scrap in the shop, i.e. control plans and SPC charting with 30% scrap reduction.

Implemented methods to increase tooling efficiency for both existing and new set-ups with 50% reduction in MRO purchases.

Responsible for writing all procedures of operation within the plant for the company’s quality manual, per ISO 9000 and FDA (IQ, PQ, OQ Validation).

Self Employed Contractor Winthrop Harbor, IL 09/13-3/14

Contract CNC and Tooling/Training Engineer

Provide detailed technical training to customers, MGF engineers, distributors and manufacturing personnel on all CNC products through on-site training courses. Provide technical support to customers and manufacturing personnel on all CNC, Robotic products, and Medical Validation.

Established new machining processes and identified requirements necessary to take a product from research and development to production using IQ, PQ, OQ.

Responsible for the production flow of the machining base and saving 10% of flow reduction.

Develop and maintain technical documentation, and course curriculum for CNC products, including programming, startup, operation, and Total Production Maintenance (TPM).

Responsible for quality and manufacturing engineering support.

Responsible for system programming for the entire shop i.e. robots leaktest and light assembly.

Implemented methods to decrease set-up time by 25% using SMED techniques.

Responsible for the implementation and installation of new equipment and materials i.e. Barfeeders, Oil Chiller, Coolant sump, High Pressure Coolant pump, Robot, Shuttle Systems and Chip Conveyers.

Past Customer is as follows, Beere Precision Medical 2000, 2001, Speedy Packaging 2009, Stellana 2009, Gem MFG 2010, Rock Island Arsenal 2010, Acme MFG 2010, Hanna Cylinders 2011, Emco Maier Corp 2013, 2014, Morgan Bronze 2013, 2014 and HN Precision 2014.

Please Note: I accepted a perm position at one of my customers that I was contracting for since 3/14.

American Metal Technologies Racine, WI 4/11-9/13

Operations Engineer

Writing all procedures of operation within the plant for the company’s quality manual, per TS16949 and ISO.

Responsible for justification & purchase of new Capital Equipment for process improvement and cycle time reduction with 10% savings.

Engineer new manufacturing processes and cells layout with meeting or exceeding quoted rate.

Responsible for training all operators and actively identify opportunities for new training classes.

Cutting tool and fixture design in SolidWorks.

Ensure all casting are free from any porosity and voids. Traveled to diecast companies to make necessary adjustments to the die mold gating and ensure an acceptable part.

Actively identify opportunities for customized training classes at each department.

CNC programming for all new manufacturing cells. Ensure all casting are porosity free and make necessary adjustment to die mold for proper flow.

6 sigma certified “green belt” and Lean MFG project.

Proto-type machining using all machine shop equipment when necessary.

Responsible for purchase of new tooling, inserts, milling cutter & new fixture.

Responsible for system programming for the entire shop both robotic and CNC equipment.

Implemented methods to increase tooling efficiency on current and new set-ups, able to get 150% more tool life with correct SFM, chip load and tool geometry.

Machinery & Factory Industrial Supply Racine, WI 2/08-9/09

Application Engineer Medical Specialist

Responsible for generating new opportunities with existing and new customers and increase sales by 10%.

Tool testing and overseeing the implementation and final results for suggested cutting tool packages with end results in 15% savings.

Implemented a Kanban system for both internal customers and external vendors as well as out

Sourcing of contract machining.

Established new machining processes identified and recommend required tooling necessary to take a project from research and development.

Targeted companies for integrated manufacturing and enhancement to install automated systems.

Responsible for writing test procedures / protocol for new Torque Limiting

oInstruments, and overseeing the implementation and final testing for said instruments to FDA standards using IQ, PQ, OQ Validation.

Development of design standards and design controls for internal and outsource process.

Responsible for the design of all new mold cavities for manufacturing

EDUCATION AND SPECIAL INTEREST

Gateway Technical College: Certified Automation Engineering

BSME United States Army Machinist School: Journeyman General Machinist

Society of Manufacturing Engineers - Senior Member

Society of Manufacturing Engineers – Cutting tools Geometries & Materials

Society of Manufacturing Engineers - Time Management – Automation Dept

American Society for Quality (ASQ) – Certified Quality Engineer

National Tool and Machinist Association: CNC Programming and Tech Math

United States Army Field Artillery School:

Albany-Chicago: 6 Sigma Certified Green Bel

Albany-Chicago: Certified VSM(Value Stream Mapping) Project Leader

Ramona High School: General Study,

Clearance (PRP Program): Top Secret US Army

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