Morristown, New Jersey, United States
Experienced project manager with a proven track record of successfully leading cross-functional teams to deliver projects on time and within budget. Expertise in strategic planning, risk management, and effective communication. Passionate about driving results and fostering collaborative work environments. Eager to bring my skills in project management to contribute to the success of dynamic organizations.
Led the design and development activities including design verification testing of 2 medical device products while simultaneously seeking regulatory/commercial approval in the US, Europe, and Japan. Directed internal and external testing activities at 3 US facilities and 1 in Ireland. Led engineering bench performance, and aging studies, including packaging validation for over twenty-five tests. Carried out root cause analysis and voice of the customer surveys in the US and Europe. Ensured compliance with FDA and European regulations. Hosted technical ad hoc and phase design reviews. Coordinated project planning meetings. Conducted data analysis to ensure product stability. • Primary contact for shelf life testing and coordinated project teams comprised of vendor personnel and offshore manufacturing partners in Ireland. • Improved efficiency and streamlined workflows by automating calculations and analysis in Excel. • Enhanced project tracking by automating processes and implementing use of Gantt charts and Pivot tables. • Played a key role in obtaining FDA PMA approval for SLENDER IDS and DIRECT RX, drug eluting stents.
Promoted to project lead for Class III medical device / combination product, SLENDER IDS. Actively involved in all stages of a 3-part modular FDA PMA application process (PMA P210014). Performed pre- and post-testing microscopic analysis and photography of medical devices during the development phase. Reviewed product specification requirements and provided data analysis to facilitate design changes. Maintained Design Verification failure investigation documentation. Coordinated shipping logistics of thousands of test samples. • Prepared critical incident reports to document failures for resolution. • Identified performance and structural issues and led special testing for modified test procedures. • Facilitated the implementation of updated performance markers. • Updated testing modifications and reports to reflect new FDA standards.
Evaluated product performance and quality during the product development stage. Served on the team responsible for design characterization, risk management, and design verification and validation. Participated in continuous evaluation of product performance and quality, risk management activities, ad hoc design reviews, and FMEA monitoring. Responsible for R&D and quality documentation. Performed on-site design verification and validation testing at US and overseas facilities. • Provided vital data used in multiple product changes to maximize performance. • Completed multiple trips to the Ireland facility to monitor manufacturing processes.