SUMMARY:

• Dedicated Management professional with expertise in design, qualification, and manufacturing of Medical, Consumer, and other government - regulated products.
• Passion for ensuring the highest level of customer safety and quality.
• Committed to fostering positive team cultures required to launch industry-changing products in a fast-paced environment.
• Leader of continuous improvement and efficiency in high-volume manufacturing environments.
• Excellent interpersonal, presentation, management, problem-solving, and communication skills.

CORE COMPETENCIES:

• Program Management
• Manufacturing Processes
• Process Validation
• Lean Manufacturing
• Product Development
• Design for Manufacture
• Plastic Molding
• Six Sigma
• International Operations
• Quality Systems
• Supplier Management
• QFD

COMPUTER PROFICIENCIES:

Microsoft Office tools (Word, Excel, Project, PowerPoint, Visio), Siemens Teamcenter, MS SharePoint, Confluence, JIRA, CAD programs (Pro-Engineer, SolidWorks, AutoCAD, Unigraphics, Cosmos FEA)

PROFESSIONAL EXPERIENCE:

Confidential, East Syracuse, NY

Engineering Manager

Responsibilities:

• Aligning direct reports of 5 Engineers plus 1 Scientist on several concurrent complex projects involving cross functional resources, contractors, and satellite production and sourcing via China and Germany
• Collaborate with Marketing to form Engineering and Operations strategies, budgets, project prioritization, and resource planning contributed to Business Line achieving 75% growth 2 years ahead of budgeted plan
• Spearheaded a department turnaround to foster a positive culture of confidence, integrity, accountability, and alignment
• Coach and mentor resources to utilize best practices such as Quality Function Deployment (QFD), FMEA, LEAN Manufacturing, 8D Corrective Action, and Plan-Do-Check-Act (PDCA) model to promote continuous improvement
• Implemented a standardized process for New Product Introduction which maintains seamless alignment of Engineering, Marketing, Manufacturing, Logistics, Sourcing, and Executive stakeholders at product launch
• Established a comprehensive Program Plan defining the scope, operational strategy, and overall program governance
• Project Management includes documenting project plan and budget, and the oversight of concepts, specifications, electro-mechanical designs, prototypes, manufacturing qualification, production release, and product sustainment

Confidential, Needham, MA

Senior Program Manager

Responsibilities:

• Managed domestic and international direct reports for the execution of typically 12-18 concurrent New Product Development Projects covering four product categories at several China Manufacturing sites
• Harmonized International and Domestic New Product Development improving on-time delivery of new products from 50% to 95%, the scope of which included compliance with Confidential and International regulation agencies, Industrial Design iterations, and consumer 5-Star Quality rating
• Developed and implemented a cross-functional business process for Product Configuration Extensions which improved consistency, reducing completion time by up to 50% while improving on-time delivery by 30%
• Organized and implemented several major initiatives for the Confidential International Program to achieve excess of 30% annual business growth of the Shark and Ninja product sales
• Collaborated on-site with China-based Executive Leadership to establish project communication and reporting plans for visibility to project tracking, project and product risks, project KPI’s, and process improvement opportunities

Confidential, Shrewsbury, MA

Project Engineer / Project Manager

Responsibilities:

• Proactively applied Lean Manufacturing concepts to streamline material movement, cutting capital and operating costs by over 15%
• Initiated Six Sigma methodologies to manage continuous improvement projects related to product, manufacturing processes, equipment maintenance, material handling, process validation, and documentation in a cGMP environment
• Introduced a User Requirement Specification ( Confidential ) procedure which cut manufacturing equipment development and validation times by 30%
• Recognition award from Contract Manufacturer owners for successful installation of ISO 13485 Quality System, customized change management system, and validated ISO Class 10000 cleanroom at new manufacturing facility, passing Confidential inspection on first audit
• Established metrics to evaluate capabilities at prospective Contract Manufacturing Operations with respect to ISO 9001 compliance, facilities, cleanroom, Confidential systems, material handling, and overall process flow

Confidential, Billerica, MA

Project Engineer

Responsibilities:

• Managed cross-functional teams domestically to develop pilot production line that was implemented and validated at Contract Manufacturer in China, successfully scaling monthly device and SMT production capacities to nearly 1M
• Created path to mass production by initiating and driving the project to increase supplier production of precision Shape Memory Alloy Wire Assembly by >10x, reducing equipment cost by 50% and component cost by 375%
• Lead the patented design of miniature electromechanical fluid pump drive assembly incorporating a specialized Shape Memory Alloy Wire
• Utilized Design for Manufacturability to create the geometry of a validated and patented 2-Shot plastic electromechanical Chassis component that incorporates the use of isolated electroplating for Confidential interface

Confidential, Plainville, MA

Mechanical Engineering Consultant

Responsibilities:

• Designed and improved specialized medical device instrumentation, fixtures, and manufacturing processes for minimally invasive spine surgery.
• Redesigned an electromechanical endoscopic device from Concept, Validation, through Implementation for use on patients during surgical procedures, eliminating a safety hazard that had caused 20% field rejects.

Confidential, Salem, NH

Mechanical Designer

Responsibilities:

• Designed custom vibration isolators for Confidential industry per technical requirements and building regulations, structural calculations approved by registered PE.
• Implemented a change management system, harmonizing customer submittals with manufactured product.