Jason Kear Email and Phone Number

Responsible for Project Management, Engineering Development, Implementation Engineering and Training departments for global manufacturer of radiopharmaceuticals.

Manage the group of project managers and PRD leaders that are responsible for all Orthopaedic Knee projects. Responsible for managing large-scale, strategic growth programs and driving program execution. Work with franchise business leaders to help define portfolio strategy and plans.

• Led all aspects of a new product development projects, including planning and scheduling, reporting progress to senior management, ensuring goal alignment between functions, analyzing both human and capital resources requirements and ensuring the project meets its agreed upon metrics.

• Manager of three engineering groups, manufacturing, continuous improvement and process development for the Urology & Women's Health Division.• Developed annual continuous improvement plans, resource plans and budgets to support improvement goals for operations and quality based metrics. • Worked with Urology franchise to develop resource and development plans for process development support of new product development projects.

• Direct oversight of 4 groups responsible for validating the following areas within the Spencer manufacturing site: Installation Qualification (IQ) for all equipment and fixtures, Operational and Performance Qualifications (OQ & PQ) of all internally produced components (i.e. molding, extrusion, and metal components), Test Method Validation, and Operational and Performance Qualifications (OQ & PQ) of all packaging and labeling processes. • Developed, implemented and trained numerous site level standard operating procedures to address gaps in the process validation procedures, including process change analysis, test method validation plans and assurance assessments.

• Project manager for Class II drug/device combination product. Multi-million dollar budget. 30+ member team. Coordination among 5 manufacturing sites and managing multiple vendor relationships. Responsible of project planning, senior and functional management communications, project resources, technical leadership, DHF maintenance, and mentoring of functional team leaders. Led project team to successful IDE approval in September 2005 and clinical trial start October 2005.• Responsible for leading cross-functional team in evaluating site needs for scale-up of combination device manufacturing, including evaluating facility requirements, clean room, equipment, quality systems, documentation system and storage. • Responsible for technical management of the drug/device combination product franchise for the Urology & Women’s Health division, including strategic planning, R&D development, resource planning, and physician consultation

• Responsible for R&D technical management of $20M+ Stone management retrieval franchise, including product portfolio and strategic planning, new R&D development, consultation on design changes and improvements, clinical usage, physician feedback, and IP management• Project manager and technical lead for 1.9F ZeroTip™ Nitinol Stone Retrieval Basket. Currently, the fastest growing retrieval basket in the division and the smallest available nitinol stone retrieval basket available on the market. Device was launched in September 2003.• Project manager of an OEM stone retrieval project, Stone Cone™ Nitinol Retrieval Coil. Device was launched in May 2002.• Corporate Technology Leverage Team Leader for Retrieval and Filtering devices responsible for being corporate point person for retrieval and filtering questions, organizing technology forums and managing site communication.• Member of the Corporate Metals Tech Team

• Technical lead on a premium upgrade ureteral stent program, Polaris™ Dual Durometer Percuflex® ureteral stent with HydroPlus™ coating. • Technical lead on a ureteral stent cost savings program which involved packaging design, and material investigation. • Early development work on a next generation ureteral stent technology involving the incorporation of an anti-microbial agent into a ureteral stent

• Successfully launched 3 product lines (1 endoscopy/2 urology) or 158 finished good codes in first year of employment worth an estimated $3.7 million in first year sales