▪ Lead design reviews under strict design control to enable a product design and material change roll out with minimal disruption to ongoing production. ▪ Manage manufacturing validations and design verification studies to qualify new components, modules, and final assembly. Requires onsite production management at international suppliers. ▪ Guide product teams through design and manufacturing failures by focusing contract manufacturing partners on root cause determination then rapidly implementing manufacturing solutions.▪ Manage engineering team responsible for product, process, and test method development.▪ Develop the Regulatory strategy for the justification of major product design and manufacturing change control submissions to TUV and FDA.

Development engineer for Class III medical devices included in the INTERCEPT technology platforms for Platelets, Plasma, and Red Blood Cells.- Led the manufacturing design transfer and validation of a new INTERCEPT single-use set through the identification of project activities and timelines, issue of specifications, creation/review/approval of manufacturing validation plans, and facilitating cross-functional meetings. - Developed new medical device packaging by creating design requirements, collaborating with vendors, sourcing prototypes, aligning on designs, and performing packaging verification and validations evaluations.- Improved the supply assurance and provide cost savings for filtration components involved in INTERCEPT single-use sets.- Generated protocols and execute in-vitro studies to evaluate new product designs and verify device quality.- Quickly fabricated and procured prototype components for feasibility evaluations.- Guided suppliers and contract manufacturers in problem solving with respect to investigations (CAPA) regarding components, processes, equipment, and test methods.- Supported resolution of customer complaints for disposables.- Authored and reviewed portions of FDA pre-market approval and CE Mark Regulatory submissions.- Managed direct report.

Functional leader of R&D and commercial product support projects focused on improving product performance and production of the INTERCEPT Blood System.- Collaborated with domestic and international contract manufacturing partners to write protocols and validate (IQ/OQ/PQ) clean room processing of components involved in a Class III medical device.- Led failure investigations leveraging root cause analysis, followed by corrective and preventative maintenance (CAPA) steps, for device components and packaging.- Created project development plans and led development FMEA exercises for the re-design of injection molded components.- Developed test protocols, leveraged expertise in interpretation of data, and used strong technical report writing to determine the functional performance of cost-saving and product improvement projects.- Transferred and validated test methods to expand internal product development capability.

Functional leader on discovery and commercialization projects focused on Brita pitcher, bottle and filter innovation.- Contributed in consumer immersion studies and focus groups to generate new product concepts.- Executed prototype development to bring concepts to life.- Engaged with cross-functional teams to ensure product design is translated accurately from concept to production.

Led research on multiple core technology discovery teams focused on improving charcoal product performance while cost saving raw materials.- Acquired strong skill set for solids quality test methods and processing. - Created foundational understanding of the progression of charcoal burn events.- Pioneered charcoal performance test methods that enabled new quality metrics, making novel cost savings rational.- Delivered the validation of product formula models which enable rapid product reformulation based on raw material commodity prices and availability.- Coordinated a nationwide product pick up and analysis of competitive product to produce data which supported product claims.

Functional leader on multiple commercialization teams, bringing new cleaning products to market.- Led product scale-up qualifications for nonwovens by independently executing manufacturing trials.- Used technical understanding of liquid processing to deliver efficient manufacturing rates and meet customer and consumer expectations.- Developed cost savings opportunity for liquid products through process improvements and built process understanding to support project charter.- Developed test standards for product quality and drove implementation of new specifications at multiple plants.

- Completed project which involved improving the filtrate media use within Brita pour-through filters.- Optimized raw material usage, filter time and filtrate performance.- Delivered a cost savings opportunity with final project recommendation.- Gained knowledge Brita test methods, performance analysis and consumer.

- Gained engineering experience working in the oil refining industry.- Calculated plant emissions for annual and monthly site wide emission reports submitted to government regulatory agencies.- Found emission reduction opportunity which led to the removal of two contaminants from annual reports.