Quality/Industria/ Project Engineer
Resume:
ROBERTO REYES
Miami, Florida 33133
**************@*****.***
PROFILE
Highly qualified Engineering Professional with over ten years of experience in positions of increasing responsibility in Quality Engineering, Industrial Engineering and Project Management.
Consistent career track record of reducing production times and costs, increasing efficiency and productivity, improving production quality and maximizing profitability for all past employers.
EXPERIENCE
Quality Engineering: Ensuring compliance of all manufacturing and production systems, processes, protocols tools and methodologies with highest standards of total quality control to provide substantial improvements in quality, reduction in cost, increased productivity and maximum competitive edge in challenging markets … expertise in use of technical and managerial tools and concepts (optimum assembly and product design, quality function deployment, statistical process control, etc.) required for economic implementation of quality assurance systems ... risk assessment and mitigation … defining performance and integrity criteria …
Industrial Engineering: Developing new methods and standards through work simplification and methods improvement to assure efficient utilization of labor and equipment ... assessing manpower and equipment requirements and allocating human and capital resources to maximize production efficiency and coordinate development and manufacturing of new products … using work sampling techniques to measure productivity ... product flow, work space and work line design and analysis ... time and motion analysis ... preparing floor plans through plant layout methodology to improve material handling ... equipment installation ... trouble-shooting ...
Project Management: Planning, design and coordination of engineering technology projects from initial concept through completion … managing cost engineering functions including development and implementation of cost control and reporting systems … preparing detailed work plans and staffing assignments for potential projects … defining, prioritizing and delegating work to be completed by engagement teams … selecting and deploying project tracking and reporting tools ... monitoring project performance against goals ... budget planning and management … managing and completing multiple simultaneous projects and tasks within time and budgetary constraints ...
EDUCATION
M.S. Degree in Industrial Engineering (GPA 3.67), 2008
University of Florida, Gainesville, Florida
B.S. Degree in Industrial Engineering (Cum Laude), 1998
University of Puerto Rico, Mayagüez Campus
Professional Training: Industrial Sterilization for Medical Devices (AAMI); Industrial Laser Welding; cGMP for the Pharmaceutical and Allied Industries; Machine Process Characterization; Industrial Statistics; Statistical Process Control …
CERTIFICATION Certified Quality Engineer Certification (pending)
EMPLOYMENT HISTORY
2009 – Present Boston Scientific, Miami, Florida
Senior Quality Engineer
Managed quality assurance and quality control functions for leading global manufacturer of innovative products, technologies and services across a wide range of medical specialties, operating in approximately forty countries with over 25,000 employees. Supervised staff of three (Quality Technician, Quality Engineer and Intern).
Implemented Core Wire Supplier (annual savings of $1 million) and Sleeve Supplier (annual savings of $300,000).
Provided logistical and engineering support for lean manufacturing implementation that saved up to $280,000 per year.
Modified Brazing Process resulting in a yield improvement of 15% and an increased process capability (CPk from 1 to 3).
2008 – 2009 Cameron Health, San Clemente, California
Supplier Development Engineer (Consultant)
Consulted on supplier and vendor functions for innovative medical equipment manufacturer with 200 full-time employees. Responsible for validation of acceptance activities, re-engineering of receiving inspection procedures and implementation of statistical process controls. Developed Component and Supplier FMEA, and supported component and supplier approval process including supplier audits.
Initiated FMEA for electrical components including development of procedures and validation of inspection method.
2006 – 2007 Guidant / Boston Scientific PR, Dorado, Puerto Rico
Engineering Internships
Completed two summer internships Software Quality Engineer (07) and Manufacturing Engineer (06). Reviewed and approved equipment and software validation, implemented acceptance activities, and expedited manufacturing investigation and fixtures development.
Performed readiness audits of laser manufacturing process to secure FDA approval inspection of a new product.
Successfully reduced product inspection time by 20%.
2004 – 2005 St. Jude Medical, Caguas, Puerto Rico
Senior Quality Engineer
Supervised Quality Inspector Group of twelve, with responsibility for incoming inspections, manufacturing and new process transfers.
Took lead role in material and production investigations.
1999 – 2003 Guidant PR, Dorado, Puerto Rico
Project Engineer (2003)
Promoted through positions of increasing responsibility for global subsidiary of Boston Scientific with ten worldwide facilities and approximately 30,000 full-time employees, producing medical technology and equipment. As Project Engineer, responsible for coordinating product transfer activities to ensure their timely completion. Functions included developing and validating such complex manufacturing processes as laser welding and bonding, and establishing inspection procedures. Directly supervised up to ten non-exempt employees and indirectly supervised two exempt employees.
Designed and implemented modifications and improvements that ensured all product transfers and prototype builds were completed on schedule with a yield improvement of 15%.
Quality Engineer (00-03)
Ensured quality and procedural compliance of up to three manufacturing lines including packaging, sterilization and incoming processes for drug products. Approved all laboratory investigations. Supervised staff of fifteen including fourteen Quality Inspectors and one Quality Technician. In addition, identified and resolved customer complaints and take measures to avoid reoccurrence. Gained hands on experience with Annual Product Reviews and Retention and Stability Programs.
Decreased laboratory testing by 15% and reduced testing costs by minimizing sample size and reducing test frequency.
Increased manufacturing yield up to 10% by identifying root causes and eliminating production errors though improving workmanship teams and implementing engineering changes.
Actively supported three new product implementations and implemented finish test for specific drug product.
Reduced lead time for manufacturing and laboratory investigations by 10% and increased lot acceptance yield by 45% by developing new mixing process.
Industrial Engineer (99-00)
Ensured optimal efficiency and productivity of all production activities a manufacturing area, including layout, line balancing, capacity studies and headcount analyses.
Maintained line balance while increasing production capacity by 30% without modifying layout.
Reduced production time by 9% and improved product flow by reducing travel distance of products from start to finish.
Additional: Additional experience in Industrial Engineering with Jansen Ortho, Watson Pharmaceutical and Kvaerner Process.
COMPUTER SKILLS Microsoft Office, MINITAB, AutoCAD, Visio.
LANGUAGES Oral and Written Fluency in English and Spanish
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