Yyyyyy x. yyyyyy

Eager and dedicated Manufacturing Operations and Engineering Professional with years of progressive experience within the technology industry. Demonstrated ability to successfully execute strategies to achieve organizational growth. Thrive in high-pressure environments that demand strict attention to detail. Adept at working effectively in both independent and team settings. Builder of effective working relationships within the quality function and cross-functionally. Possess a track record of achievement in the design and commercialization of medical devices and equipment, high-tech electronic components and consumer products for Fortune 500 and specialty manufacturing entities at the domestic and global levels. Manufacturing Engineer or Head of Manufacturing Operations role that will allow for leverage of skills, as well as offer prospects for career growth.

Medical Device Manufacturing | FDA & MDD-Regulated Medical Devices | Engineering Operations | Quality Assurance & Control

Quality Systems Regulations | Analytical Skills | Strategic Planning | New Product Launch | Cross-Departmental Teamwork

Change Agent | Financial Acumen | Supply Chain Management | Communication | Leadership | Project Management

Process improvement | Lean Manufacturing | Six Sigma | Demand Flow | ISO xxxxxx, 9000, 9001 and cGMPs

Security & Facilities Management | Renovations | Electronic Documentation Viewing System | Ask | Baan | Infor LN

SAP & SAP Variant Configuration | Agile PDM | CAD | AutoCAD | Windows NT | Microsoft Office, Visio

ERP Systems/Software Implementation | Data Analysis & Migration | Database Administration

Sivantos Group Ÿ 2009-Present

Sr. Engineering Manager SCM, North America

• Serve in a SCM Lead capacity to drive overall ERP System Implementation of InFor LN, as well as related data analysis and migration
• Facilitate the introduction of new products including global system deployments and sustaining engineering functions
• Developed and currently manage a global product configuration database for multi-site custom product manufacturing across more than 30 domestic and international functions
• Work in a Database Administrator capacity for North America and organize workflow by brand
• Strategically coordinate and steer projects to ensure on-time, on-budget delivery
• Lead documentation control across multiple sites throughout North America
• Demonstrate experience daily as it pertains to CAPA, internal audit and complaint management systems
• Work as the QMS Lead in managing all global documents and processes
• Also engage regularly in key performance indicator (KPI) data analysis and reporting
• Oversee Quality System Management duties, including compliance with FDA GMPs, ISO xxxxxx, CAPA, as well as internal and external audits
• Gained hands-on experience with Agile PLM/PDM and SAP variant configuration
• Work in a Security Head capacity to administer building security measures; also lead facilities management including the development and execution of significant renovation projects

Siemens Hearing Instruments, Inc. Ÿ 1994-2008

Project Coordinator/Junior Project Manager (2000-2008)

• Spearheaded global product configuration and database management for multi-site custom product manufacturing
• Drove positive change management, including product introduction across 29 domestic and international locations
• Developed and introduced a Training Database used by employees to track logged hours
• Gained vast experience in using Agile PLM/PDM, as well as SAP variant configuration
• Acted in a Security Head capacity for SHI-USA to manage the installation and administration of security functions
• Handled facilities management efforts including much-needed renovations

Yyyyyy x. yyyyyy

Manufacturing Engineering System Manager, 1994-2000

• Executed the use of Demand Flow Technology and LEAN manufacturing practices
• Completed electronic hardware layouts, global process design and all related documentation
• Crafted an all-inclusive design for a database and led maintenance of all online electronic documentation viewing system (EDMS) worldwide
• Developed and controlled custom configurations for worldwide manufacturing (Variant Configuration) product databases

VitalTrends Technology, Inc. Ÿ 1990-1994

Vice-President of Manufacturing Operations

• Hand-chosen by the company to establish and supervise manufacturing operations for a medical start-up company
• Headed various functions including Logistics, order entry, production, quality control, facilities management and documentation control among additional core duties

Datascope Corp. Ÿ 1980-1990

Manager, Manufacturing Operations

• Led production assembly, manufacturing engineering and materials support Instrumentation processes
• Worked as a Program Manager across new product development and launch for numerous Class 3 medical devices; served in team settings to achieve or surpass organizational goals

Bachelor of Science, Industrial Engineering, Xxxxxx Institute of Technology (With Honors)

Member, Society of Industrial Engineers

Vice President, Hanover Park High School Basketball Booster Club