Objective Utilize my training and expertise in the areas of engineering management, system design, product design and production with a high emphasis on quality.
Summary of qualifications Design, Project, and Manufacture Engineer with a diversified experience in the formulation, development, analysis, testing, and validating of new processes and/or modification of products, equipment, and facilities. Career encompasses significant background in process controls, system manufacturing analysis and design, troubleshooting, validation, and computer aided design in the medical manufacturing field. Processes revolving around Biopsy Forceps, Guidewires, and Gastro-Intestinal products. Processes involving electroplating, specialty coatings, along with the ability in rapid prototyping design and implementation with cGMP and ISO regulatory emphasis. An efficient and effective team member and project/team leader with a unique blend of managerial, technical, and communication skills. A strong commitment to achieve objectives with capacity to utilize and coordinate internal and external resources in order to insure timely completion of projects assuring the highest level of quality.. I have been involved with FDA and GMED audits managing the backroom, along with reviewing quality manual against 20 CFR 820 and ISO 13485. I have also been involved in Product and Process validations including writing Standard Operating Procedures.
Professional experience 2009-2011 Contractor
Engineering Contractor
• Worked in orthopedic company implementing a project management program for new products with pedicle screws and peek implants.
• Helped organize CAPA system and implemented a system for tracking internal and external complaints including helped with investigations.
• Completed summaries of CAPA’s for BSC for FDA Audit.
• Gap analysis of Quality systems on validations.
• Programmed Two (2) Scarab Robots for welding Heart Pump devices.
2005-2009 Boston Scientific Corporation Miami, Florida
Equipment Engineering Manager
• Implemented systems incorporating project management tools to effectively and efficiently managing equipment builds for projects throughout facility with a capital budget greater than $5 million dollars.
• Part of product development team for Endosurgery in Watertown, Mass to help develop processes to manufacturer an Endo scope.
• Created metrics to track productivity for the Equipment Engineering team. Metrics were effective tool in forecasting monthly expenses allowing planning at 80% of budget.
• Lead transfer manager reporting to corporate on sub-assembly processes transferring to four different facilities. Responsible for resourcing, budgeting, capex, vendor auditing and quality assurance planning.
2003-2005 Boston Scientific Corporation Miami, Florida
Project Manager
• Mentored product builders in achieving their Yellow Belt Six Sigma Certification two months ahead of schedule and better overall result in the attainment of their objectives.
• Effectively managed a 1.2 Million dollar line transfer to BSC facility in Costa Rica two months ahead of schedule and at 80% of planned budget.
• Began managing all Capital Expenditure plans for the Equipment Engineering department ensuring actual would not exceed planned budget.
2001-2003 Boston Scientific Corporation Miami, Florida
Principal Manufacturing Engineer
• Effectively managed over seven different product families.
• Managed six engineers and seven technicians.
• Managed a process validation for Injection Gold Probe with deliverables exceeding expectations in yields and efficiency.
• Ran successful DOE for Gold Plating Line leading to upper management decision to re-launch the Gold Plating process.
• Successfully validated the re-launch of the Gold Plating process for the Rotawire product family.
• Help execute over $500,000.00 in scrap savings for the Rotawire product family.
• Project technology lead for all equipment transferred from the Watertown, Mass. facility to Miami.
1998 – 2001 Boston Scientific Corporation Miami, Florida
Senior Manufacturing Enginee...
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