Manufacturing Quality Systems Regulations, ISO Standards Expert Consultant Resume
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Resume of ECY Consultant
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  • Lean Manufacturing
  • New Product Manufacturing
  • Quality

This expert has a MBA, received through the University of Phoenix.

This expert has a B.S. in Industrial Engineering, received through the University of Puerto Rico, Mayaguez Campus.

This expert is a CIAPR Licensed Engineer (EIT), passed PE exam.

Manufacturing Quality Systems Regulations, ISO Standards Expert Consultant Resume
 

This expert has experience in engineering and manufacturing management, providing leadership, management, planning and administration for manufacturing and process engineering departments.

This consultant is experienced in lean manufacturing and six sigma applied to supply chain manufacturing, value stream mapping, and methodology for lean transformation (including 5's).

As a strategic engineering manager, this consultant is EIT Licensed, PE exam approved, and Lean-Sigma / Six Sigma Green Belt Certified. This expert has also been recognized as a Lean-Sigma Champion. This consultant possesses leadership, analytical, planning, and interpersonal skills, and is fully bilingual (English and Spanish).

Consultant, Kevin Kennedy Associates Inc.

Providing expertise in manufacturing quality systems regulations and ISO standards, industrial engineering management, manufacturing management, providing leadership, management, planning and administration for manufacturing and process engineering, and related expertise to a wide variety of clients.

 

Sr. Manufacturing Manager (Diabetes Engineering and Manufacturing Manager), Medtronic Puerto Rico Operations Co., Juncos, PR

Provided leadership, management, planning and administration for the Manufacturing and Process Engineer Departments. Assured design, intent and reliability of projects was met by proper process implementation and design. Lead the Manufacturing, Engineering, Compliance, Facilities and Information Systems efforts when transferring new products or technology. Developed, managed and justified Annual Operating Plan as well as Capital Projects Budget. Developed and executed business strategies, SWOT (Strengths, Weakness, Opportunities and Threats), VMOST (Vision, Mission, Objective Strategies and Tactics) and fiscal year objectives to meet business goals and objectives. Acted as Champion for Manufacturing and Engineering Lean Six Sigma Projects. Served as manufacturing representative during US / Foreign Governments and Corporate such as FDA, ISO13485, Brazil, and Japan audits. In addition, developed and implemented a strategic plan to control project expenses which had reached $6M over budget. Project expenses were controlled and potential financial impact was reduced by over $500K. Reduced overtime within the highly automated area from 18 to 1% and headcount by 38% after implementing a cross training program and establishing specific goals to manufacturing employees. Schedule adherence was also increased from 80 to 101%. Reduced overtime within the labor-intensive area by 10% and increased output per headcount by 14%. Developed and implemented a Business Plan within the Engineering Department to update and maintain departmental activities, preventive maintenance, Corrective and Preventive Actions (CAPA), engineering change orders and support manufacturing operations. Preventive maintenance program reached 100% compliance and CAPA's past dues was reduced from 17 to 3 items. Designed and implemented a Business Continuity Plan to be followed by Engineering and Manufacturing departments during natural disaster situation.

 

Sr. Manufacturing Manager (Neuro Manufacturing Manager), Medtronic Neuro Puerto Rico Operations Co., Villalba, PR

Directed, managed and controlled the Manufacturing and Industrial Engineering operational activities. Assumed overall responsibility for managing, planning, budgeting, implementing and maintaining operational costs, methods and employees. Led the Manufacturing and Industrial Engineering efforts when transferring new products or technology in conjunction with other technical groups. Developed and executed in conjunction with other operations management team company policies and procedures that affect local and global manufacturing operations. Led manufacturing and engineering activities to achieve CAPA completion. Acted as Champion for Manufacturing and Industrial Engineering Lean Six Sigma Projects and assist the Manufacturing Director. Served as manufacturing representative during FDA and ISO13485 audits. Identified and implemented key performance indicators to track and measure absorption, absenteeism, outputs and start per line per day production. Increased manufacturing favorable variance by 10%. Developed, and maintained long term Capacity tools in alignment with business operational growth needs. Professionally developed team leaders through development program. Three resources were promoted. Management efforts were recognized and special recognition was received from participants. Successfully led Supply Chain Department on a temporary assignment. Implemented 5's at the manufacturing areas resulting on approximately 1% yield improvement.

 

Manufacturing Superintendent (Neuro Manufacturing Manager), Medtronic Neuro Puerto Rico Operations Co., Villalba, PR

Directed, managed and controlled activities relating to the manufacturing operation, industrial engineering and technical support and provided technical guidance on operational issues. Developed and executed Annual Operating Plan Budget and Capacity Planning. Conducted continuous efforts to improve manufacturing operations, decrease lead-time, streamline work processes, and provide quality devices. Led manufacturing and engineering activities to achieve CAPA completion. Assisted the Operations Manager. Served as manufacturing representative during FDA and ISO9000 audits. Developed, deployed and implemented capacity management tools and manufacturing performance metrics. Implemented resources monitoring and control plan (FY04 – 12% reduction). Increased favorable manufacturing variance by 10% applying lean manufacturing concepts and Theory of Constraints concepts.

 

Sr. Manufacturing Engineer, Medtronic Neuro Puerto Rico Operations Co., Villalba, PR

Managed and coordinated the manufacturing operations including adherence to project goals and production schedule. Provided proactive support to Neuro Manufacturing Operations, technical expertise to engineers and technical support to production personnel. Identified needs and developed manufacturing documentation, tooling and equipment. Initiated, evaluated, and approved engineering change orders. Analyzed and determined conformance of material and assembly. Led manufacturing activities to achieve CAPA completion. Participated in the new product development and product/project transfer. Developed training and cross training matrix to maximize flexibility and capacity management within the manufacturing area. Was appointed as Manufacturing representative during FDA, and ISO9000 audits. Team Winner WORLD CLASS MANUFACTURING Outstanding Award (Time Measurement, Line Balancing, Kanban system). Pull System Implementation PR Leader resulting on a Finished Goods inventory reduction of approximately 10MM (Distribution Center Inventory reduction from 6-8 weeks to 3.5 weeks). Reduced absenteeism from 5% to 3.1% and product cost by 5%.

 

Manufacturing Engineer, Medtronic Neuro Puerto Rico Operations Co., Villalba, PR

Generated manufacturing procedures for new products following Quality Systems Regulations and ISO standards and updated existing procedures. Revised proposals for new product specifications. Provided adequate and timely disposition to non-conforming product. Led product and technology transfer activities including qualifications, validations, process and process flow improvements, line balancing and capacity management. Implemented Ergonomic Program including training for new hires and advanced training for technical resources. Transferred New Deep Brain Stimulation Therapy exceeding completion schedule. Received Individual Performance recognition for the achievement.

 

Maintenance Engineer, Baxter CVG Anasco, PR

Provided engineering support to manufacturing areas during implementation of new product manufacturing processes and acquisition of new equipment, including manufacturing area or equipment modification. Developed and executed IQ, OQ, PQ, line validation, engineering change orders, discrepant materials evaluation and capacity management. Transferred new AVA therapy including multiple process improvement within schedule. Reduced labor standard by 5% through resources utilization improvement.

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Peter specializes in welding and metallurgical engineer with 40 years industry experience in commercial nuclear power plant construction.

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