Experience

Transonic Systems Inc.

• United States
• Medical Device
• 1 - 100 Employee

• Vice President of Manufacturing

  • Jan 2023 - Present



Convergent Dental

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

• Director Of Manufacturing

  • Jul 2021 - Dec 2022



Covaris

• United States
• Biotechnology Research
• 1 - 100 Employee

• Director Of Manufacturing

  • Jan 2019 - Jul 2021



Augmenix, Inc.

• Manufacturing Manager

  • Feb 2017 - Dec 2018

  ● Responsible for management of Manufacturing, Facilities, Purchasing, Shipping, and Manufacturing Engineering. ● Manage a mixed team of exempt and non-exempt employees. ● Responsible for production planning to meet current customer demand and business objectives. Ensured no backorders for products occurred. ● Develop COGS and budget for Operations. ● Responsible for the coordination of engineering activities for process improvements, support for product … Show more ● Responsible for management of Manufacturing, Facilities, Purchasing, Shipping, and Manufacturing Engineering. ● Manage a mixed team of exempt and non-exempt employees. ● Responsible for production planning to meet current customer demand and business objectives. Ensured no backorders for products occurred. ● Develop COGS and budget for Operations. ● Responsible for the coordination of engineering activities for process improvements, support for product development, and support to current manufacturing lines. ● Develop and manage shipping procedures to existing and new markets. Point of contact for distribution. ● Managed the Operations move from a smaller facility to a new larger custom-built facility. • Designed the Manufacturing and Laboratory area. Created floor plans for optimized flow and defined required utilities. • Created the overall project plan coordinating facilities, operations, and quality action items. • Specified and ordered all new capital equipment and furniture to expand the current productions lines. Scheduled the delivery of all equipment to coincide with a tight window of freight elevator availability. • Drafted all validation documentation (Equipment IQ, OQ, PQ, Clean Room, and overall Product Validation) • Coordinated the movement of personnel and equipment to the new location with minimal production disruptions. ● Managed the expansion of Augmenix’ s new facility which doubled the facility size.

• Senior Manufacturing Engineer

  • Jul 2015 - Feb 2017

  ● Oversaw the scale up of manufacturing from 3 million to 50 million in sales. ● Implemented new equipment, processes, test methods, and documentation to support manufacturing scale up. ● Provided engineering support to several product lines and quick response to production issues. ● Responsible for maintaining inventory and purchasing of all raw materials used in the manufacturing of Augmenix’s products. ● Provided support for all audits as Operations representative. ●… Show more ● Oversaw the scale up of manufacturing from 3 million to 50 million in sales. ● Implemented new equipment, processes, test methods, and documentation to support manufacturing scale up. ● Provided engineering support to several product lines and quick response to production issues. ● Responsible for maintaining inventory and purchasing of all raw materials used in the manufacturing of Augmenix’s products. ● Provided support for all audits as Operations representative. ● Managed productions issues with contract manufacturers. ● Created all documentation necessary for the Canadian launch of Augmenix’s SpaceOAR product and prepared the physical/digital DHF. ● Identified and executed several design improvements for Augmenix’s products. ● Developed and executed PM activities for all production equipment. ● Coordinated all routine testing for Augmenix’s products



Waters Corporation

• United States
• Biotechnology Research
• 700 & Above Employee

• Advanced Manufacturing Engineer

  • Apr 2014 - Jul 2015

  ● Provided engineering support to several electromechanical and opto-mechanical product lines. ● Created and maintained work instructions. ● Ensured proper documentation is completed to meet quality systems requirements (BOM’s, Routings, genealogy). ● Designed tooling and fixtures to improve manufacturing processes and acted as the tooling supervisor. ● Developed Engineering SOPs to support standardized work. ● Managed the transfer and development of the manufacturing process… Show more ● Provided engineering support to several electromechanical and opto-mechanical product lines. ● Created and maintained work instructions. ● Ensured proper documentation is completed to meet quality systems requirements (BOM’s, Routings, genealogy). ● Designed tooling and fixtures to improve manufacturing processes and acted as the tooling supervisor. ● Developed Engineering SOPs to support standardized work. ● Managed the transfer and development of the manufacturing process for two new product lines. ● Worked to ensure the design for manufacturability of these new products. ● Evaluated and provided disposition for rejected material, electromechanical, and opto-mechanical assemblies and performed root cause analysis when necessary. ● Supported global production sites. Show less ● Provided engineering support to several electromechanical and opto-mechanical product lines. ● Created and maintained work instructions. ● Ensured proper documentation is completed to meet quality systems requirements (BOM’s, Routings, genealogy). ● Designed tooling and fixtures to improve manufacturing processes and acted as the tooling supervisor. ● Developed Engineering SOPs to support standardized work. ● Managed the transfer and development of the manufacturing process… Show more ● Provided engineering support to several electromechanical and opto-mechanical product lines. ● Created and maintained work instructions. ● Ensured proper documentation is completed to meet quality systems requirements (BOM’s, Routings, genealogy). ● Designed tooling and fixtures to improve manufacturing processes and acted as the tooling supervisor. ● Developed Engineering SOPs to support standardized work. ● Managed the transfer and development of the manufacturing process for two new product lines. ● Worked to ensure the design for manufacturability of these new products. ● Evaluated and provided disposition for rejected material, electromechanical, and opto-mechanical assemblies and performed root cause analysis when necessary. ● Supported global production sites. Show less



KARL STORZ Endoscopy-America, Inc.

• Medical Device
• 700 & Above Employee

• Manufacturing Engineer

  • Nov 2011 - Mar 2014

  ● Produced new designs to ensure manufacturability of new prototypes. ● Implemented a new coating that ensured compatibility with common medical device sterilization procedures. This coating is projected to generate 1.7 M in new sales for 2013. ● Managed several engineering projects with large capital acquisition components. ● Researched and developed new mechanical and materials technology for use in future and existing products. ● Designed, installed, and qualified equipment and… Show more ● Produced new designs to ensure manufacturability of new prototypes. ● Implemented a new coating that ensured compatibility with common medical device sterilization procedures. This coating is projected to generate 1.7 M in new sales for 2013. ● Managed several engineering projects with large capital acquisition components. ● Researched and developed new mechanical and materials technology for use in future and existing products. ● Designed, installed, and qualified equipment and fixtures. ● Designed and implemented new manufacturing processes. ● Technical document writing. ● Designed and initiated engineering test protocols. ● Worked closely with suppliers to develop new products, and enhance current ones. ● Implemented a new process aids that reduced related process time by over 30 percent. ● Knowledgeable in fabrication methods including machining operations (including metal finishes and finishing), injection molding, and investment casting. Show less ● Produced new designs to ensure manufacturability of new prototypes. ● Implemented a new coating that ensured compatibility with common medical device sterilization procedures. This coating is projected to generate 1.7 M in new sales for 2013. ● Managed several engineering projects with large capital acquisition components. ● Researched and developed new mechanical and materials technology for use in future and existing products. ● Designed, installed, and qualified equipment and… Show more ● Produced new designs to ensure manufacturability of new prototypes. ● Implemented a new coating that ensured compatibility with common medical device sterilization procedures. This coating is projected to generate 1.7 M in new sales for 2013. ● Managed several engineering projects with large capital acquisition components. ● Researched and developed new mechanical and materials technology for use in future and existing products. ● Designed, installed, and qualified equipment and fixtures. ● Designed and implemented new manufacturing processes. ● Technical document writing. ● Designed and initiated engineering test protocols. ● Worked closely with suppliers to develop new products, and enhance current ones. ● Implemented a new process aids that reduced related process time by over 30 percent. ● Knowledgeable in fabrication methods including machining operations (including metal finishes and finishing), injection molding, and investment casting. Show less



Parexel

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Lead Imaging Research Associate

  • May 2007 - Nov 2011

  ● Worked with clients on the technical management of their medical imaging trials and provided expertise on correct imaging practices. ● Worked on a interdisciplinary team to design a prototype phantom scan dummy for calibrating DXA scanners. Led the engineering team that selected the design criteria, materials and schematic of the prototype. ● Responsible for initiation and maintenance of client investigator site trial imaging, including maintenance of site qualification documents… Show more ● Worked with clients on the technical management of their medical imaging trials and provided expertise on correct imaging practices. ● Worked on a interdisciplinary team to design a prototype phantom scan dummy for calibrating DXA scanners. Led the engineering team that selected the design criteria, materials and schematic of the prototype. ● Responsible for initiation and maintenance of client investigator site trial imaging, including maintenance of site qualification documents, investigator correspondence and related tracking documents. ● Performed initial quality review and tracking of received exam images. ● Corresponded with sites including acceptance or query documentation for each incoming case. ● Helped to set up imaging trainings for radiologists. ● Worked on a Global Integration team in order to increase the networking and support between the various global offices. ● As a project lead worked on standardization procedures for my projects. ● Performed quality control on incoming clinical trial data. Show less ● Worked with clients on the technical management of their medical imaging trials and provided expertise on correct imaging practices. ● Worked on a interdisciplinary team to design a prototype phantom scan dummy for calibrating DXA scanners. Led the engineering team that selected the design criteria, materials and schematic of the prototype. ● Responsible for initiation and maintenance of client investigator site trial imaging, including maintenance of site qualification documents… Show more ● Worked with clients on the technical management of their medical imaging trials and provided expertise on correct imaging practices. ● Worked on a interdisciplinary team to design a prototype phantom scan dummy for calibrating DXA scanners. Led the engineering team that selected the design criteria, materials and schematic of the prototype. ● Responsible for initiation and maintenance of client investigator site trial imaging, including maintenance of site qualification documents, investigator correspondence and related tracking documents. ● Performed initial quality review and tracking of received exam images. ● Corresponded with sites including acceptance or query documentation for each incoming case. ● Helped to set up imaging trainings for radiologists. ● Worked on a Global Integration team in order to increase the networking and support between the various global offices. ● As a project lead worked on standardization procedures for my projects. ● Performed quality control on incoming clinical trial data. Show less



University of Massachusetts Lowell

• United States
• Higher Education
• 700 & Above Employee

• Teaching Assistant

  • Aug 2009 - Jan 2010

  ● Prepared and taught undergraduate lab sessions. ● Worked closely with faculty to manage and run undergraduate engineering courses. ● Graded technical papers for the courses. ● Prepared and taught undergraduate lab sessions. ● Worked closely with faculty to manage and run undergraduate engineering courses. ● Graded technical papers for the courses.