Experience

Prodct
• United States
• Business Consulting and Services
• 1 - 100 Employee
• Advisor

  • Jan 2023 - Present


Sonablate Corp

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• VP of Strategic Operations

  • Apr 2022 - Jan 2023

• VP of Manufacturing Operations

  • Aug 2020 - Apr 2022

• Sr. Direct of Operations and VP of Manufacturing

  • Jan 2020 - Aug 2020

• Sr. Director of Operations

  • Aug 2018 - Jan 2020

• Director Of Manufacturing

  • Jun 2015 - Aug 2018

  Charged with establishing short and long term objectives for manufacturing while driving a culture of Operational Excellence across the organization. Organize manufacturing engineering staff to establish and accomplish improved efficiency and continuous improvement goals to reduce costs. Manage personnel involved in assembly, testing, distribution of finished goods and supplier management to ensure high quality products are built and shipped to meet agreed upon delivery schedules and cost objectives. Define manufacturing processes, including layout, concepts, controls, and statistical measures.

• Supplier Relations Manager

  • Feb 2014 - Jun 2015

  Responsible for establishing, negotiating and maintaining strong supplier relationships to improve the performance of the company. Also responsible for identifying opportunities to develop strategic relationships with key suppliers, establishment of quality agreements/contracts and raw material specification agreements, cost savings, establishment of operating procedures, and managing and reporting of key supplier performance metrics.

• QA Project Manager

  • Dec 2012 - Feb 2014

  Responsible for supporting a wide range of company initiatives including Quality System compliance activities as well as the review and implementation of industry best practices, cross functional projects with linkage to the Quality System, application of current methodologies for the analysis of data throughout the company and other projects as assigned.



Hologic

• Hospitals and Health Care
• 1 - 100 Employee

• Supplier Development Engineer

  • Mar 2011 - Nov 2012

  Responsible for identifying and developing new suppliers as primary or secondary sources for new and existing products. Additionally responsible for leading investigations of non-conformances, troubleshooting root cause and driving necessary specification changes or supplier corrective actions. Partner with New Product Development to identify, evaluate, and validate supplier processes for new products in addition to working with other functions to identify and implement quality improvements and cost saving opportunities. Lead supplier audits and report on supplier performance.



Boston Scientific

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Engineer II, Quality

  • Feb 2010 - Apr 2011

  Overall responsibilities include providing support for all Supplier Quality related activities with a primary focus on packaging (sterile barrier) and labeling. Assist in Receiving Inspection operations, supplier survey/audit responsibilities, and new product development operations. Assist suppliers in formation of statistical sampling plans, inspection methodology, and procedures. Assist in the qualification, selection, and development of new suppliers as needed. Provide project direction, coaching, and mentoring for engineering and technical team personnel. Participate in the implementation of process controls and CAPA systems designed to meet or exceed internal and external requirements pertaining to supplier changes.



Chart Industries

• United States
• Industrial Machinery Manufacturing
• 700 & Above Employee

• Sr. Quality Engineer

  • Dec 2009 - Feb 2010

  Covidien’s Oxygen Therapy product lines were acquired by CAIRE Inc. a division of Chart Industries. Job title and responsibilities were retained after the acquisition with the exception of increased number of direct reports. Overall responsibilities include the management, monitoring, and improvement of the Quality Management System of the plant as well as managing direct reports which include Quality Engineers, Quality Inspectors, and the Material Test Laboratory. Covidien’s Oxygen Therapy product lines were acquired by CAIRE Inc. a division of Chart Industries. Job title and responsibilities were retained after the acquisition with the exception of increased number of direct reports. Overall responsibilities include the management, monitoring, and improvement of the Quality Management System of the plant as well as managing direct reports which include Quality Engineers, Quality Inspectors, and the Material Test Laboratory.



Covidien

• United States
• Medical Device

• Sr. Quality Engineer

  • Dec 2008 - Dec 2009

  Responsible for the overall maintenance and improvement of the Quality Management System through supplier qualification and monitoring, component qualification, process validation, and proactive product improvement and corrective action activities- Manage, train and provide guidance to all plant Quality Engineers.- Work directly with Manufacturing, Factory Service, R&D and Engineering to assure quality considerations are adequately covered in design, testing, and release of materials, components and completed products.- Serve as Quality Assurance representative in the absence of the Quality Manager.- Successfully completed Covidien’s Six Sigma Black Belt training program and project requirements for certification.

• Quality Engineer

  • Jan 2006 - Dec 2008

  Responsible for maintaining and improving the Quality Management System through the implementation of appropriate procedures, policies, controls, specifications and monitoring. Also responsible for improving products and manufacturing processes across the full spectrum of medical device Quality Assurance activities.

• Manufacturing Engineering Technician

  • May 2005 - Jan 2006

  Responsible for troubleshooting production/process problems while maintaining compliance with company and regulatory procedures, guidelines and company change control procedures. Modified and developed existing/new equipment, tooling, fixtures, and process parameters for safety, quality, and productivity.