SUMMARY

• Manufacturing/Process/Quality Engineer with over 17 years of engineering experience in electromechanical, plastic injection molding, PCB, tractor, motor coach, and medical device manufacturing industries.
• Experienced in production, planning, Quality Control, Quality Assurance, Quality Engineering, Continuous Improvement Initiatives, CAPA, Test Method Validation, Statistical Process Control (SPC) techniques, product planning/monitoring from inception to completion, Lean Manufacturing principles, 5S, Six Sigma, Process Validation, Value Engineering as well as preventative maintenance procedures (PM), in ISO 9001 and FDA (ISO 14971, ISO 13485) regulated environments.

TECHNICAL SKILLS

Quality Control Tools: Quality System Training; FPMEA (Process Failure Mode and Effect Analysis); Root Cause Analysis, Corrective Action/Preventive Action (CAPA), Supplier Corrective Action (SCAR), ECO (Engineering Change Order)/ECR (Engineering Change Report)/ECR/ECN creation, SPC (Statistical Process Control); Six Sigma Methodology, 5S, Quality Tools such as 8D, DMAIC, Fish Diagrams, Control Charts, and Lean Manufacturing Principles; Value Stream Mapping, Value Engineering, SOP (Standard Operating Procedures), MRB (Material Control Board); Gage R&R studies; Blueprint readings skills.

Microsoft Office Applications and Tools: Microsoft Office Word, Excel, PowerPoint, Outlook, VISIO, Picture Manager, and Publisher; Able to manipulate data to useful information (Pivot Table, Minitab).

Other Software Applications/Database Management: Adobe’s FRAME Maker 7.1, ORACLE 11i Database, GENESIS, STK, Sigma for Simulations, TimerPro (Time Studies), PDM/PLM tools Enovia, FACTORYworks, Agile, ADAPTIV, JD Edwards; TrackWise.

Quality Management Systems Implementations: ISO 9001 Quality System; FDA Regulations; ISO 13485; CAPA Methodology; Process Validation (IQ/OQ/PQ); Test Method Validation; UL Regulation Systems; DFM (Design for Manufacturability); CAM (Computer - Aided Manufacturing); Ability to read blueprints (GD&T).

Personal Skills: Ability to communicate effectively (verbally and written) ability to make sound decision within established guidelines; able to work without supervision; dependable, conscientious worker, detail-oriented; adaptable, fast-learner; time management skills; ability to prioritize given tasks; PowerPoint presentation skills; team-player, excellent follow-through skills; technical writing skills.

PROFESSIONAL EXPERIENCE

Confidential, Warsaw, IN

Quality Engineer/PMSS Engineer

Responsibilities:

• Reviewed and analyzed customer complaints data for trends and safety signals;
• Led cross-functional meetings on Safety Signal Reports, Post Market Surveillance data and customer complaints analysis reports for review with Business Unit Leadership teams;
• Participated in Product Escalation activities to ensure corrective actions were takes in a timely manner per established procedures.

Confidential, Warsaw, IN

Quality Engineer

Responsibilities:

• Developed and updated Quality Acceptance Criteria (QAC) to insure features are properly identified for inspection on production floor in agreement with engineering drawings;
• Optimize QAC to improve quality throughout manufacturing and at final inspection areas while ensuring product functionality and behavior via online SPC monitoring;
• Initiate change requests for quality improvements (Change Orders), CAPA related tasks, and document all changes through teh appropriate control systems using Agile, TrackWise and other internal Quality System databases;

Confidential, Warsaw, IN

Manufacturing Engineer

Responsibilities:

• A member of teh Process Validation Remediation team working on quality investigational work in area of chemical passivation, electro-cleaning and electro-polishing of orthopedic parts;
• Performed cleaning validation activities in terms of writing protocols, execution and process validation report writing (IQ/OQ/PQ);
• Updated existing work instructions, procedures, training materials, Standard Operating Procedures (SOP’s), and process Flowcharts;

Confidential, Fridley, MN

Manufacturing Engineer

Responsibilities:

• A member of teh Remediation Team in charge of compliance issues with DMR’s (Device Master Record);
• Worked on Indexing DMRs of all purchased and manufactured components in teh Neuromodulation division;
• Conducted meetings to prepare for internal and external FDA audits;
• Identified bottlenecks and create procedures on creating DMR indexes;
• A member of teh Process Validation Remediation team working on creating PFMEAs, updating Standard Operating Procedures (SOPs), and performing process validation activities (OQ/PQ/IQ).

Confidential, East Peoria, IL

Process Planning Manufacturing Engineer

Responsibilities:

• Daily use of VPPA (Teamcenter 8.3) Visual Process Planning Application software for processing assembly products and completing special work assignments;
• Administered teh assembly NPI (New Product Introduction) processes to ensure teh Engineering drawings are released and processed on time for NPI builds and monitor all teh NPI’s from a quality perspective;
• Participated in problem solving activities using Quality Tools such as Value Stream Mapping, Fish Diagrams, 8D, 5 W’s, DMAIC, and Pareto Charts
• Participated in Six Sigma projects involving safety improvement for production personnel;
• Work with internal and external suppliers to develop and manage projects to ensure efficient and cost-effective systems and processes to produce quality products.

Confidential, Redmond, Washington

Manufacturing Engineer

Responsibilities:

• Assisted with teh creation and development of manufacturing processes and procedures such as work instructions, SOPs, forms, travelers for shop floor personnel as well for ISO-9001 audit purposes;
• Trained shop floor personnel on quality engineering tools such as Controls Charts, Fish diagrams, Pareto Charts and Check Sheets;
• Performed time and motion studies using TimerPro Software as part of Continuous Improvement initiatives and reduction of cost;
• Played a major part in teh transition from paper to electronic PDM (Product Data Management) system for documentation and quality engineering drawings.

Confidential, Aurora, Ohio

Manufacturing Process Engineer/MRB

Responsibilities:

• Worked cross-functionally with problem solving teams to meet requirements of quality, reliability, and profitability;
• Interfaced with suppliers on a regular basis to identify quality issues and find solutions;
• Participated and took leading role in quality troubleshooting circles, Corrective and Preventive Action (CAPA) activities, and Lean Manufacturing initiatives to reduce scrap and promote Continuous Improvements (CI);
• Improved existing process documentations to comply with FDA rules and regulations;
• Played a leading role in teh Non-Conforming Material Control Board (MRB) Team, responsible for teh disposition of products in a timely and cost-effective manner.

Confidential, Tempe, Arizona

Product Engineer

Responsibilities:

• Responsible for hardware, component end-of-life, Bill of Materials, and Revision Managements of electronic assemblies and subassemblies using ECOs (Engineering Change Order) tools;
• Acted as teh liaison, coordinator, and focal point by interfacing with cross-functional problem-solving teams to meet quality, optimization, delivery, and cost goals of teh organization;
• Provide reports on customer complaints and field reports to management and strived to find root causes.

Confidential, Phoenix, Arizona

Product Planning/Manufacturing Engineer

Responsibilities:

• Interfaced with customers to analyze requirements, standards, drawings and specifications for compliance with generally accepted PWB design/fabrication specifications and compare them to facility manufacturing capabilities;
• Built step-by-step manufacturing processes required to create routings (travelers) based on DFM (Design for Manufacturability) input results, customer blueprints/specifications, and purchase orders for shop floor personnel to perform individual tasks.
• Participated in identifying and implementing Lean Manufacturing principles on teh production floor;
• Prepared for ISO 9001 audits by performing internal process audits and writing reports for review by Quality Management teams;