Teresa Nelson, Mba, Pmp Email & Phone Number

I 𝗛𝗲𝗹𝗽 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗼𝗺𝗽𝗮𝗻𝗶𝗲𝘀 𝗕𝗿𝗶𝗻𝗴 𝗟𝗶𝗳𝗲-𝗦𝗮𝘃𝗶𝗻𝗴 𝗧𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝘆 𝘁𝗼 𝗠𝗮𝗿𝗸𝗲𝘁—𝗢𝗻 𝗧𝗶𝗺𝗲 𝗮𝗻𝗱 𝗪𝗶𝘁𝗵𝗶𝗻 𝗕𝘂𝗱𝗴𝗲𝘁I specialize in providing expert project management for medical device and combination products, helping businesses navigate complex regulatory environments, manage cross-functional teams, and meet critical deadlines. I understand that launching a new product or.

Boston, Massachusetts, US

• Project manager for Boston location of a global cross-functional team comprised of hardware and software engineers, project managers, delivery managers and account managers focused on development and test of an.
• Collaborated with engineers, project managers and delivery managers at local and global locations to develop and maintain project schedule and budget, communicated status to management.

Charlotte, North Carolina, US

• Led international cross-functional team to define project scope, schedule and risks of Atlantis cement-retained and screw-retained zirconia dental crowns (Class II) and Atlantis temporary crowns (Class I) medical.
• Led EU MDR transition project for Atlantis products. Collaborated with Engineering, Regulatory and Quality to develop DHF update schedule and track progress.
• Project manager for SaMD project with goal of creating cloud-based product design software.
• Collaborated with R&D and Global Product Management to define annual crown enhancements for material additions, process improvements and new product features.
• Site superuser of Accolade project management lifecycle software

Charlotte, North Carolina, US

• Managed new product validation and transfer to production activities; driving projects to completion through the coordination and collaborative efforts of finance, marketing, sales, quality, supply chain, production.
• Customer liaison throughout the development and production process; balanced diverse and conflicting priorities while providing customer transparency to schedule and budget throughout the project.
• Ensure compliance to FDA regulations and customer design specifications, achieved successful validations through the application of Six Sigma and statistical data analysis methodologies.
• Planned and executed numerous validations for manufacturing equipment, sterilization process, sterile barrier seals, accelerated aging and assembly processes.

• Engineering lead on drug and medical device projects with responsibility for driving product development, enhancements and improvements, and sustainability initiatives.
• Managed contract designer, contract manufacturer and product testing for light device approved on FDA 510(k): Responsible for resolution of product technical challenges, FMEA, user needs documentation, designed and.
• Engineering Lead for new drug product launched Q1 2007.
• Collaborated with supplier of injection-molded component to apply Six Sigma methods to execute a critical design of experiment (DOE) to identify root cause of molding issue, leading to improved part fill and parting.
• Provided technical support to internal and external customers to resolve installation and operational questions or issues.

Chicago, US

• Team leader of cross-functional mini filter project team; established project goals and timelines for product design and launch.
• Managed suppliers in the design and build of new R&D equipment and injection molding tools.
• Supported manufacturing to resolve design and process issues.
• Authored SOP's, FMEA's, purchase specifications, technical reports, and equipment maintenance procedures to document new products and processes.

US

• Led project team during European clinical trial and validation efforts to support submission for CE Mark and US IDE.
• Managed all aspects of the project life cycle including budget, schedule, team meetings, documentation, communications, and conflict resolution.

Newburyport, MA, US

• Managed multiple packaging projects through all phases: quoting, design conceptualization, prototype and production tool design, process development, customer first article approval and transfer to manufacturing.
• Communicated with customers, field sales engineers, manufacturing, and suppliers as required to achieve project objectives and timelines.

Master Of Business Administration (M.B.A.), Global Management

Bachelor Of Science (Bs), Business/Integrated Supply Chain & Operations Management

Associates, Mechanical Engineering Technology