Catherine O'Donnell Email & Phone Number

Morrisville, North Carolina, United States

Morrisville, North Carolina, United States

-Led proposal efforts to generate competitive offerings on a wide variety of life science projects from early feasibility studies and front-end loading estimate phases to detailed design and construction support phases.-Supported interdisciplinary teams to provide design projects to clients on schedule and within budget by managing internal cross-functional meetings and external client facing meetings. -Maintained meeting minutes, design review decisions, and action registers for design projects as well as facilitated quality review sessions for design drawing issuances.

North Haven, Connecticut, United States

- Managed all phases of a suture capacity expansion program including procurement, installation, & validation of 12 new pieces of equipment across 3 different production areas at North Haven, CT. - Effectively manage relationships and lead core team meetings with cross-functional departments & external vendors - Direct accountability to leadership steering committee to report out project status, risk analysis, & resource utilization - Managed the program scope, schedule, & cost - Support the Site Packaging Engineering team establish a program plan for all packaging projects & resource utilization

North Haven, Connecticut, United States

- Leading 3 multimillion-dollar capital investment projects for capacity expansion relating to needle electropolishing, finished good suture packaging, and monofilament suture extrusion - Facilitate and lead cross-functional teams through quote review meetings and design review meetings with vendors - Led an A3 investigation to reduce equipment issues causing production scrap and downtime resulting in identifying 12 root causes, implementing 7 corrective actions, and reducing the average maintenance labor hours per year from 250 to 208 hours - Supporting an R&D project for a new process step, scCO2, that will eliminate multiple current process steps for suture production - Continue to support Plant projects including COS conversion of a packaging cell to create one-piece flow in a mature, stable environment

North Haven, Ct

- Support different medical device production lines to troubleshoot equipment issues, update SOPs/SWIs for process improvement, improve safety concerns, address quality issues, and maintain efficient running of the production line to continuously produce quality products for our customers - Led CAPA investigations following the DMAIC process and implemented corrective actions to eliminate defects, including aiding in the improvement of a barcode system to eliminate labeling issues - Supported the transfer of a product line from NPD to Plant and ensured all documentation for maintenance, engineering, quality, and manufacturing were adequate and easily accessible. - Led a team to resolve a production line down by implementing a short-term in-process inspection to detect non-conforming product and validated an optimized oven recipe to eliminate the creation of the defect as a long-term correction - Managed the day to day activities & projects for a summer intern

North Haven, Ct

- Led NCR investigations to determine root causes for visual and performance defects of sutures - Executed and analyzed a DOE to obtain the optimal sealing parameters to seal spooled suture material in foil pouches - Executed and wrote multiple validations (IQ/OQ/PQ) for production equipment/processes and updated SOPs to reflect these new validated parameters- Worked with a vendor to ensure the critical dimensions of a kit component were within specification as the vendor was changing resin materials and completed a PPAP to validate this material change

Reading, Pennsylvania Area

- Completed testing & documentation to aid in the verification & validation of the Sustain™ Technology on products in the global market- Set up and executed redox reactions to activate the surface of catheters creating anti-microbial and anti-thrombotic features- Assisted in project management activities for the release of an acute hemodialysis catheter including compiling testing reports & completing documentation to keep the project on schedule- Analyzed data after testing of Sustain™ modified catheters to understand the effects of the surface activation chemistry and how to improve durability and functionality of catheters - Participated in weekly meetings to communicate ideas and results between two locations to keep the project on target for its goals and schedule including an FDA 510k approval

Mannheim Area, Germany

- Designed and tested the functionality of experimental setups to determine the best setup for future experimentation - Created and performed experiments compressing an air bubble surrounded by liquid to replicate an occlusion in the tubing- Analyzed the data from these experiments for future use in creation of a model to aid in the alert system of the pump - Effectively communicated goals and results within my team and in the preparation of bi-weekly project status updates

Boston, Ma

Aided in establishing a biofilm removal process using biosensor devices, Super Plasmon Resonance imaging (SPRi) and Quartz Crystal Mircobalance (QCM)

Beverly, Ma

- Assisted with review and validation of AutoCAD drawings of P&IDs and isometrics delivered to clients - Helped to develop and maintain an online filing system for all engineering documentation transmitted to the client- Participated in client meetings, demonstrating 3D models of the chemical reactor system being developed - Traveled on business trips, to complete a review of the P&ID documentation and to inspect the equipment being built- Communicated with clients about the specifics of the design and made modifications in the final design

- Assisted in locating and evaluating hazardous and non-hazardous disposal options for clients - Participated in researching recyclable and beneficial re-use options for clients’ waste

Bachelor Of Science, Chemical Engineering

Activities and Societies: Engineers Without Borders (EWB), Society of Women Engineers (SWE), American Institute of Chemical Engineers.

Master Of Engineering Management

Education record