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 product extension involves high stakes, and every delay can mean missed opportunities and delayed patient care.With a deep understanding of FDA, ISO, and other regulatory requirements, I help you avoid costly delays and regulatory setbacks through a streamlined, step-by-step project management process. Whether you’re developing a new product or scaling an existing one, I ensure your project stays on track, so you can focus on innovation and delivering impactful solutions to the market.𝗛𝗼𝘄 𝗶𝘁 𝘄𝗼𝗿𝗸𝘀:✔️Consultation – Assess your project’s challenges and develop a tailored plan.✔️Custom Roadmap – Create a compliance-focused, actionable project timeline.✔️Ongoing Management – Manage the complexities of execution, ensuring every milestone is met.When you work with me, you’ll reduce risk, save time, and gain peace of mind knowing your project is in expert hands.Ready to get your medical device to market faster? Let’s talk about how we can make that happen.

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 electro-mechanical IVDR system for a medical device client based in Europe.• 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 devices, complete design control activities, develop software specifications and implement releases for software component of project, comply with FDA, Canadian and EU medical device regulations, develop and transfer manufacturing process to EU site to support launch in global markets.• 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 and engineering.• 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 implemented product and packaging qualifications and reports, conducted supplier audits and attended initial product build at supplier to verify process qualification.• 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 line strength to produce a quality component.• 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