Engineer Manager

James Donald Budovec

408-***-**** Email *********@*****.***

EDUCATION

Masters of Science in Industrial Management from Northern Illinois University - May 2003

Areas of Study Included: ISO9001; Six Sigma; Materials Management; Lean Manufacturing; Project Management

Bachelors of Science in Industrial Technology Engineering from Northern Illinois University, May 1999

WORK HISTORY

Affymetrix – Thermo Fisher Scientific July 2013 – Present

Staff Process Engineer

Process Sustaining Engineer providing technical and sustaining engineering support to all aspects of operations. Also, establishes and refines operating specifications, improves manufacturing techniques, and production yields, and introduces new processes to improve production efficiencies.

Outline with Suppliers requirements for product validation, including CtQ, Reliability, Performance, Manufacturability, Risk management (FMEA) to support the Zero Defect Objective

Conduct strategic root cause investigations utilizing DOE to determine a statistical significant variable related to failures modes

Develop Supplier quality agreements and quality control plans to ensure compliance with quality standards and product specifications

Participated in QRB and Supplier Management Review actives

Provided ongoing support for all Supplier Quality related activities. Provided assistance for supplier audits, and new product FAI (First Article Inspections) and validation lots

Developed a 12 module Lean Program shared by 3 current Affymetrix manufacturing sites

Trained on both Minitab and JMP to perform statistical analysis during trouble shooting exercises

Developed new product labels and packaging drawings utilizing SolidWorks

Co-instructed 3 Six Sigma Green Belt class that included 31 participants that yielded 20 Green and 11 Yellow Belts

Haskel Milton Roy – Hamilton Sundstrand (United Technologies Corp) June 2008 – July 2013

Process-Product Quality Engineering Manager

Direct Reports include 6 Receiving Inspection Associates, 1 Supplier Quality Engineer, 1 Manufacturing Engineer

ACE Quality System facilitator – Practitioner

oConduct onsite and offsite 5-day events at other domestic and international Hamilton Sundstrand locations. Trainings include: Manufacturing & Business Value Stream Mapping; RRCA (Relentless Root Cause Analysis) Kaizen: Standard Work Kaizen; PQ Analysis Capability Studies; Kaizen Cellular Designs; QCPC Turnback/Escape Manager; ACE Associate Level Superday Training; RRCA Quality Clinic Certifications

Developed and Certified the RRCA Quality Clinic in Burbank. 12 departments report into the QCPC online application identifying weekly turnbacks and escapes. Annual reduction of repetitive turnbacks across the 12 departments collectively increased overall efficiencies by 25% since its conception

Spearheaded the renovation of a labor intensive Receiving Inspection report process, and replaced it with an automated electronic application for Quality Dispositioning. Long-term benefits include the elimination of internal requests from departments requiring copies of Certs, as these files are now available electronically.

Senior Manufacturing Engineer

Directed the design and development of three High Pressure Nitrogen Test Stands for 2 Haskel Gas Booster cells and 1 Air Amplifier cell. Implemented flow racks and Kanban 2-bin point-of-use systems to reduce assembly and set-up time (de-trashing) time by 50%, and Stockroom kit picking time by 25%, for 45 common use parts within the 3 cells. This reduced the kitting time by 25 minutes per work order, which was an annual savings of $150k

Led project in the Class 100 Clean room to remove the outdated manual process required to manually measure the particles in a microscope for each completed work-order after oxygen cleaning. The 10 second automated Particle Test Sampling increased the number of work-orders completed each day from 6 to 8, and saved over $80k in labor costs annually

Steered completion of Sub-Sea Valve Test API-6 ISO 10423 Certification of 7 high-pressure valves. This project included a Cleaning and Flushing System, installation of a Jib Crane in assembly, Hydrostatic Test Stand, Electronic Data collection system, and a Temperature bath. The completion of the Sub-Sea validation will generate potential long term financial gains as the market demands require stipulations requiring API-6 for all Sub-Sea valves

Boston Scientific - Advanced Bionics October 2007 – May 2008

Production Supervisor

Responsible for all production activities for the Auditory Coil Case Electrodes sub-assemblies, Devices, and 35 direct reports

Lead the DMAIC Auditory Device Assembly Production Defect Reduction and Process Improvement Project. Project goal established to reduce the number of defect per month by 90%

Improved Level Loading across the Coil Case Electrodes production area based on labor standards for each operation to obtain a more consistent workflow. Color coded techniques implemented to better control traceability of Devices to travelers while units are placed in ovens during cure cycles

Member of the Auditory Risk Assessment/ MRB Team

Audited manufacturing area for cGMP and FDA compliance accuracy and completion

Cardinal Health – Biotechnology and Sterile Life Sciences July 2005 – February 2007

Interim Shift Manager - Senior Packaging Shift Supervisor

Coordinated the daily production and scheduling of a 35 Room Blow-Fill-Seal Pharmaceutical process

Conducted training for compliance under (GMP) Good Manufacturing Procedures, as required for all Production Associates

Developed improvements to enhance performance of each line, which increased yields, reduced down time, and also reduced the number of reworks

Implemented Lean Kanban of all resins and raw materials throughout the warehouse. Developed VMI (Vendor Managed Inventory) relationships for most controlled raw materials with controlled status

Verified accuracy of quantity and identification of finished goods and raw materials through data inquiries and adjustments within JD Edwards

Conducted investigations for deviations of current procedures. Developed and executed corrective actions pertaining to these deviations

Baxter Health Corporation – Medication Delivery March 2004 – July 2005

Supervisor-II Manufacturing Non-Ceph

Supervised Non-Ceph manufacturing Cell, overseeing Fill, Finishing, Mix, with 23 direct reports

Mix QWT Leader – implemented preventive measures to correct all late batches, provide continuous improvements, and reduce the total number of exceptions by 25%, using totals from 2003 as a baseline

Oversaw correct procedures were exercised during sterilization for subsequent production requirements

Ensured proper (GMP) Good Manufacturing Procedures, and FDA requirements were followed by all Production Operators, Supply handlers, and Production Associates, within Non- Ceph Fill room, Finishing Rooms, and Mix complex within a aseptic environment

Applied Composites Corp January 1999 - March 2003

Production Manager

Supervised the daily production and planning for a three shift per day operation schedule for 125 employees in a union plant

Implemented FIFO (First In First Out) supplies, 5S, Kanban systems, and JIT (Just In Time) inventory methodologies that resulted in a reduction in waste and inventory holding costs that exceeded $300,000 annually

Refined Standard Operating Procedures (SOP) for all current running product that led to a direct reduction in cycle time

Performed Failure Mode, Effects, and Criticality Analysis (FMEA). Compiled and analyzed Statistical Process Controls (SPC) data. The use of the SPC data, coupled with deployment of Lean Manufacturing techniques, led to a reduction in waste and improvements in customer quality satisfaction, along with a 65% reduction in RGA

CERTIFICATIONS

Completed Project Management - 12-hour certification program at Northern Illinois University - May 2003

Six Sigma-Greenbelt certification program - Northern Illinois University - Naperville Illinois Campus, March 2004

OTHER SKILLS & ACTIVITIES

Tool & Die Maker-Plastic Injection Molds: 15years, Solid Works, Minitab, JMP, AutoCAD-Inventor; Society of Plastics Engineers; U.S. Navy Reserves

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