Mary Beth Padgett, Pmp, Pe Email & Phone Number

Wake Forest, Nc

Manage multiple programs and Program Managers for technology company developing sonar, telemetry, radar, communication and deployment and recovery systems. Responsible for P&L for $120+M business.

Wake Forest, Nc

Senior Program Manager for technology company developing sonar, telemetry, communication and deployment and recovery systems. Plan and manage schedule, budget, subcontractors and staffing and direct technical activities for multiple programs including company's largest program with $100+M budget.

Project Manager for development of nutrition product using innovative filling and laser sealing operation. Responsible for filling and sealing process and equipment development, and defining and meeting project schedule. Project had been ongoing for 5 years with limited technical progress. Developed project plan, optimized equipment and processes, and resolved technical issues to meet end customer’s requirements in 8 months.

Provided design and material change recommendations for the Black Ice Oral Syringe Dispenser. Recommendations yielded significantly improved syringe performance with results that were equivalent or better than all competitive products. Also responsible for component vendor selection and approval, validation and verification testing.

Project Manager for production transfer of surgical instrument manufacturing line with 100+ catalog items from one plant to another. Manufacturing processes included CNC milling and other machining operations as well as detailed hand work. Job included the management of 3 direct reports, planning, executing, and controlling all activities within sending and receiving facilities. This required executing equipment transfer, planning and purchase of equipment as needed, managing and planning inventories, resource acquisitions, establishing and monitoring of all required documentation (per FDA and company policies), developing and maintaining MS Project schedules and budgets, including reports and communication to management as well as across multiple facilities and teams. Led development of transfer strategy and inventory build plans to minimize risk of production interruptions while providing contingency plans. Responsible for plant layout of cells and training plans for new operators.

Responsible for high profile safety syringe program including management of cross-functional project team, product design and testing, purchase and design overview of automated assembly line and injection molds, validation of process and equipment, all project documentation to meet QSR and Design Control requirements, program costs and schedule, and transition to Manufacturing. Also led root cause anlysis teams and called in to lead team to completion on another program which was behind schedule.

Lead engineer for state-of the -art low cost safety syringe for a start--up company in Vancouver BC, Responsible for concept development, prototyping and testing, FDA approvals and establishing production capability. Experience with injection molding, manufacturing processes, andautomated assembly equipment.

Lead development engineer for prosthetic joint implants and instruments. Responsible for product from concept design through release to market, including cadaver bone sizing studies, 3D CAD modeling, clinical trials and introduction to the medical community. Development required working closely with a team of orthopedic surgeons, observations of surgical procedures in the OR and knowledge of implantation and surgical techniques.

Designed and implemented state-of-the art single use consumer medical products. Specific products included a new 1/2ml syringe with a 20% cost savings over its predecessor, a new 3/10ml syringe, and supporting products such as packaging and insulin storage devices. Experience with injection molding, product design and testing, packaging equipment, and automated assembly equipment.

Msme, Mechanical Engineering With Emphasis On Biomedical Engineering

Bsme, Mechanical Engineering