Engineer Manufacturing

Tommy L. Dail Jr.

Grand Prairie TX.***** Home: 817-***-**** Email: adhxdf@r.postjobfree.com

PRINCIPAL LEVEL QUALITY MANUFACTURING ENGINEER

Creating a successful result driven environment that achieves or exceeds corporate expectations for our customers.

Twenty plus years successfully meeting or exceeding customer requirements and expectations. Recognized for superior capability in evaluation of manufacturing process, identifying improvements and implementing improvement strategies. Twenty plus year’s substantially reducing manufacturing cost as a result of increasing quality, reducing cycle time, reducing material cost and moving to automation. Over twenty years of successful validations (IQ, OQ, PPQ, and TMV) and execution experience. Over twenty years of proven exceptional project management leadership and success. Fifteen plus years experience in quality assurance and quality control. Over fifteen years of excellent complaint, S.C.A.R and C.A.P.A closures.

Lead product team to successfully identify process and material issues, defined and implemented corrective actions that turned a deteriorating product line with a 10% yield into a 97% yield company accomplishment.

Successfully completed detailed production line evaluation that lead to 60% cycle time reduction and improved quality. This was accomplished by designing automated equipment and process restructuring using lean M.F.G. and six sigma techniques.

Demonstrated effective leadership by playing a major role in developing a team work atmosphere and turning a project that was eighteen plus months overdue and idle, into a company success story in five months.

Appointed by the President, as project manager for the company move into a new facility (C.E.R, admin, labs, shipping and receiving, marketing, clinical, all aspects of move), Responsible for a six million dollar move budget.

Lead product development teams in defining manufacturing requirements, product mfg. cost, designing mfg. process, equipment and purchase, validations (IQ, OQ, PQ, TMV, Protocol and Report), Identifying outside suppliers, fixturing and tooling, production line setup

Medical Device Industry

And Pharmaceutical

Manufacturing Procedures & Engineering Change Orders (ECO)

FDA, ISO, 21 CFR Part 820, ISO 13485 and QSR

Lean Manufacturing

Six Sigma

Process Continues Improvement

Trouble Shooting

Product Transfer from design to mfg.

Minitab 16 Statistical Software

Failure Mode & Effects Analysis

Design Control – PFMEA - DFMEA

Excel, Word, PowerPoint, Project, Visio and Outlook

ASTM – ANSI – GMP - 5s - 5Why

APOP – PPAP – DMAIC

Professional Experience:

Serta Simmons Bedding Dallas TX

Quality Engineer / Technician Aug 2016 to Oct 2019

Dallas Plant Closed

Performed detailed data production line evaluations that lead to 25% cycle time reduction and a 35% quality improvement as well as a 20% cost savings. Accomplished by identifying actual issues and root causes through data and investigation. Implemented corrective actions that proved to achieve company and teams requirement.

Achieved highly effective (S.C.A.R & C.A.P.A) investigations on incoming and manufacturing non-conformances materials, worked with suppliers to address quality issues and ensure appropriate corrective and preventative actions were implemented. Conduct supplier plant visits/audits and report performance to management.

Foster a safety culture and the implementation of safety policies and training in compliance with the company safety program and OSHA regulations to eliminate work related injuries.

Achieved Certified Quality Trainer requirements and Successfully Trained New Associate's on SSB Quality Standards, SOP's Federal Regulation 16 CFR 1633 (Mattress Fire Barrier System) and other quality requirements. Also trained new technicians.

Performed new product Pilot setups, runs and compiled all required documentation for new product qualifications.

Wrote comprehensive quality standards and procedures that helped improve quality by 35%. Simple operators had no idea of what was acceptable and what was not acceptable, once trained quality drastically improved.

Monitor and review CTQ / SPC/Error Proofing Controls at every level. Collect, analyze, and report data and participate in improvement projects.

Maintain line quality metrics and dashboard and participate in quality reviews. Monitor and review CTQ / SPC/Error Proofing Controls at every level. Collect, analyze, and report data and participate in improvement projects.

Johnson & Johnson Ethicon Inc. San Angelo TX

Sr. Quality Engineer (BEPC Contract Position) Oct 2013 to March 2016

Contract Expired

Leader of project teams that successfully accomplished company objective through clear communication, team-building, remaining calm under pressure, strong problem solving-skills and quality experience.

Performed comprehensive investigations of process and material nonconformance that facilitated the determination of root cause, remedial action, implementation and effectiveness monitoring.

Approved product and final dispositions for nonconformance, compile information, completed product impact assessments; determine bounding, sampling plan determination, risk level and lead teams to correct nonconformance closure.

Management and review of FDA 21 CFR Design History File, Device History Record and Device Master Record.

Obtain data from LIMS, exported to excel, manipulate data according to need, export into Minitab statistical software and create x-bar standard deviation graphs for team. Also created other Minitab graphs for NCR and CAPA data analysis. Good at using Excel and Minitab software package.

Conducted internal quality audits ensuring compliance with 21 CFR Part 820, ISO 13485 and QSR.

Perform process and material continues improvement quality assessments, identifying areas of quality improvements, cost reduction, none value add activity as well as gaps in current process. Then with this information determined the Current state which allowed the future and ideal states to be identified.

Reviewed, approved and demoted engineering change orders (CO) and change assessments (CA) for major validations and document improvement changes. Investigated periodic reviews and determined dispositions.

Lead product team to successfully identify process and material issues, defined and implemented corrective actions that turned a deteriorating product line with a 10% yield into a 97% yield company accomplishment.

Designed power point presentations for both management and project team presentations with detailed Microsoft Project timelines.

Lead project teams in composing PFMEA, DFMEA, IQ, OQ and PQ validation documentation.

Abbott Inc. Irving TX

Sr. Quality Validation Engineer (Contract Position) June 2012 to Feb 2013

Contract Expired

Effectively researched, defined, wrote and executed equipment and process validations (IQ, OQ, PQ and TP’S) and all other required documentation essential to accomplish an exceptionally detailed and accurate quality validation.

Effectively validated Freezers (from -10 C to -86 C) and Refrigerator (from 2 C to 8 C, Walk-in also)Validation included mapping using a calibrated Validator 2000 thermocouple system with up to 36 thermocouple locations.

Demonstrated excellent leadership and negotiation expertise when working with cross functional teams to prepare, execute and complete validations.

Prepared positive impact PowerPoint presentation that clearly explained to the equipment and process owners the reason Validation is required, how the validation process is executed, and a timeline of the expected length of the validation and the zero cost to their cost center.

Attended required training, trained on all quality documentation, and applied Good Manufacturing Practices.

St. Jude Inc. Plano TX

Sr. Manufacturing Engineer (Contract Position) Nov 2011 to Feb 2012

Contract Expired

Develop robust master validation plans for manufacturing product lines that met medical device federal regulation and international standards.

Defined, wrote and execute process validations (TMV, IQ, OQ and PQ with protocol and report) and all required documentation essential to the validation.

Define and manage timeline; attend meetings and present status of project.

Identify process improvements that improve quality, lower cycle time, cuts cost and meet customer satisfaction requirements.

Quest Medical Inc Allen TX

Senior Manufacturing Engineer June 2008 to June 2009

To better utilize my experience

In charge of the company’s MPS Disposable flagship product line as well as over 70 smaller products.

Responsibilities included all MPS Disposable Complaints, Production Line Support, New product and process development; product line continues improvement systems, rewriting and creation of new documentation (MAPS, QA, SOP, DOP, DMR, and DHR).

Performed detailed production line evaluations that lead to 60% cycle time reduction and improved quality. This was accomplished by designing automated equipment and process restructuring using lean M.F.G. and six sigma techniques.

Manage Design History File (DHF), Device History Record (DHR) and Device Master Record (DMR).

Performed detailed corrective and preventive actions (C.A.P.A) which included issue identification, investigation, corrective action, implementation, verification and closing.

Executed detailed complaint investigations that lead to corrective action on production lines that greatly improved the process, quality and customer satisfaction of product.

Responsible for automated adhesive dispensers, conveyer belt production equipment, tubing cutters, Kabar RF welders, leak testers, Pouch and tray sealers, in process and final inspection.

Performed six process validations (Includes IQ, OQ and PQ). Updated or created Inputs, outputs, hazard analysis, product specifications, and bill of material, manufacturing procedures and all other documents required.

Successfully launched two new product lines with a 95% and 97% starting yields.

Boston Scientific Corporation Santa Clara CA.

Senior Manufacturing Engineer Oct 2000 to Sept 2007

Manufacturing moved to Puerto Rico

Designed the preeminent manufacturing engineering department, with a hundred percent focus on production and maintenance. Developed a cohesive staff that out performed company expectations. Demonstrated exceptional leadership managing a staff of five engineers and four technicians.

Closed over one hundred complaints (includes detailed investigation, root cause analysis, detailed corrective action or appropriate response and monitoring). Complaints closed with excellent customer satisfaction. The Sr. Manager of Complaint department made me an offer to be the complaint manager.

Lead product development teams in defining manufacturing requirements, product mfg. cost, designing mfg. process, equipment and purchase, test method validations (protocol and report), Identifying outside suppliers, fixturing and tooling, production line setup.

Designed lean manufacturing process and implemented continues improvement programs on all critical product lines.

Appointed by the President, as project manager for the company move into a new facility (C.E.R, admin, labs, shipping and receiving, marketing, clinical, all aspects of move), Responsible for a six million dollar move budget.

Established and lead a team in a complete overhaul of the preventive maintenance, process validation standard operating procedures (IQ, OQ and PQ).

Identified critical issues and opened C.A.P.A (corrective and preventive action); performed detailed root cause investigation, corrective action, implementation, verification and closing.

Addressed customer complaints with a 100% customer satisfaction and confidence in the investigation, corrective action and verification that was performed.

Developed a new product development system for operations. This included creating operation strategy, MS project timeline, designed presentations for concept, technical, design, production readiness and market release design reviews.

Design and manage Design History File (DHF), Device History Record (DHR) and Device Master Record (DMR).

Trained and mentored engineers, manufacturing associates, and other department leaders on successfully transferring of new product from development to manufacturing.

Demonstrated an Outstanding ability to build a great cross functional work environment.

Responsible for purchasing over two million dollars in manufacturing equipment, fixtures, tooling.

Chosen to mentor four interns, all of whom at graduation returned to work for Guidant Corporation and proved to be a great asset to the company.

Keravision Inc. Fremont CA

Senior Manufacturing Engineer June 1998 to Sept 2000

Company filed bankruptcy

Played a major role in the recreation of the Keravision quality system.

Developed and implemented an in-house labeling process and control System.

Demonstrated a high level of leadership, and competence when chosen to take on the responsibility

of manufacturing engineering manager during the managers seven and a half-month illness; after being on the job five weeks.

Developed goals for the engineering department and organized department to successfully exceed corporate expectations in the areas of manufacturing, complaints, and C.A.P.A improvements.

Conducted audits and developed action teams to address issues found during audits.

Directed Mfg. Engineering department in preparing protocols, final reports,

manufacturing instructions, quality instructions, process validations, equipment

qualifications, preventive maintenance, calibrations, non-conformance reports and

corrective action reports.

Developed a computerized engineering system to put required information in a format

that can be used to increase engineering efficiency.

Originate and control Design History File (DHR), Device History Record (DHR) and Device Master Record (DMR)

Developed the first Keravision quality team made up of mfg. operators.

Purchased and performed detailed test method validation on Keravisions first automated inspection system, developed the process, programs and implemented. This one system eliminated three operations, allowed the company to inspect parts to .005mm, cut inspection time by two hours per Intac pair.

Responsible for Dac CNC lathes, blocking and CNC mills, labeling & bar-coding,

packaging, deblocking operations, final and in process Product inspection.

Biocompatibles Cardiovascular Division Sunnyvale CA

Senior Design / Manufacturing Engineer July 1997 to May 1998

Company moved to Ireland

Actively participated in initial market viability and technical

feasibility of new product. Also Market Analysis and Product Brief.

Demonstrated effective leadership by playing a major role in developing

a team work atmosphere and turning a project that was eighteen plus

months overdue and idle, into a company success story in five months.

Create and Manage Design History File (DHR), Device History Record (DHR) and Device Master Record (DMR).

Designed a new Stent Delivery Catheter product.

Worked with outside vendors to design, test and manufacture product.

Developed project plans, timeliness, budget and responsible for

purchasing over $900,000 in machinery, fixtures, tooling.

Responsible for clean room setup for production and transferring product

from design to production.

Accomplished a 90% yield from day one of manufacturing. The highest

yield the company had seen up to this time was 60%.

Contributed to all aspects of ISO9000, CE mark and quality management system.

Endosonics Corp. Pleasanton CA. Manufacturing Manager / Engineer Oct 1990 to June 1997

Company Moved To Sacramento

Excelled at directing a cohesive staff in the successful attainment of objectives. Managed staff of up to forty full- time employees, consisting of two technicians, two leads and 36 operators.

Compiled, analyzed and presented test data for product validation.

Developed documentation for new product release, such as product specification, test plan, hazard analysis, bill of materials, material specifications, product manufacturing procedures, incoming, inprocess and final inspection procedures.

Complete manufacturing Engineering and product management of product Transfers from design to manufacturing.

Outstanding hardware and software computer skills. I effectively use Microsoft windows, excel, word, power point, access and a host of other Software packages (learning CAD program).

Identified potential problems and existing problems, diagnosed causes, and determined corrective actions.

Setup pilot production lines for new products, redesigned problem areas, designed tools and machinery for automation, line balancing, continues improvement program, training system, most important established effective teams and teamwork atmosphere.

Implemented GMP training program, contributed to the implementation of ISO9000.

Self-starting, Self Motivating, goal-oriented strategist whose confidence, perseverance and vision promote success.

Tech-Aid Temporary Service Oakland, CA.

Incoming, In-process and Final Inspection Nov 1984 to Sept 1990

Inspected product according to procedures and blue print specifications.

Performed complex first article inspections.

Responsible for sterilization Processing.

Performed GMP compliance audits.

Developed and maintained documentation system.

Developed reliability test methods on products and performed reliability testing.

Performed statistics analysis of test data.

Organized incoming, inprocess and final inspection departments.

Trained personal in incoming, inprocess, and final inspection.

Assisted in the development and implementation of Quality system.

Sierra Designs Oakland CA.

Incoming, In-process and final inspection Inspector. Aug 1983 to Oct 1984

Inspected products according to procedures and blue print specifications.

Followed and trained personnel in GMP.

Developed new In process inspections to ensure the highest quality product was produced

and those problems would be caught as early in the process as possible.

Education:

C.E.T.A. Trade Institute - Evanston IL - Graduated

Machine Technology, Mechanical Engineering and Drafting.

Northbrook Community College - Northbrook IL - 2 Semesters

Course Work in Business, Communications and Computer Science.

Evanston Township High School - Evanston IL - Graduated

04/22/2020 - REVISION A

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