Product Design Owner for PD Cyclers

Managed the product verification team for the Round Lake Renal Care team-Managed a team of nine people and nine laboratories. Laboratories performed several types of testing (exploratory/feasibility, formal verification, biohazardous/microbial, device servicing/calibration).-Developed the testing strategy for peritoneal dialysis products.-Ensured laboratories, validated equipment, and testing practices met internal and external quality requirements.-Developed strategy to source biohazardous substances for R&D testing.-Worked with Global R&D partners to ensure successful collaboration on R&D projects and sharing of best practices.

Provided systems engineering support and leadership for home hemodialysis and peritoneal dialysis devices-Investigation lead for a peritoneal dialysis clinical trial. Investigated and resolved critical field issues for a system of medical devices (electromechanical and disposable) and coordinated activities with a cross-functional team.-Led the development of therapy level use cases, user needs, and system requirements for a new product. Ensured that therapy level requirements cascaded down appropriately to lower subsystem components.-Lead engineer responsible for developing a water sampling strategy for a peritoneal dialysis system. Developed a strategy that met critical regulatory and business case requirements. -Led a work stream responsible for microbial testing for a dialysis system. Responsible for leading a cross-functional team to define the test strategy, develop a testing schedule, and investigate issues that occurred during V&V testing.-Risk management lead for a home hemodialysis device. Updated the risk file during product support and performed MAUDE analysis review.-Water Device Systems Lead -Led a cross-functional team to investigate and resolve critical field issues. -Investigated alternate water devices use in a new product design. Determined if the alternate water devices were feasible for use from a technical standpoint and led the activities to do a tear down and cost comparison of the devices -Provided technical guidance and systems leadership on technical issues and compliance with standards -Led activities to determine options for installation of a water device in a patient home use environment. Identified user needs and business case requirements. Worked with a cross-functional team to identify installation components that would address critical use case/business case requirements.

Provide Systems Engineering support and leadership for various projects across Electromechanical Products R&D. Experience in requirements analysis, verification, human factors testing, change control and impact analysis, product labeling,and process improvement. Product knowledge of infusion pumps and hemodialysis machines.

Engineer in an Engineering Development Program (EDP) at Baxter Healthcare in Northern Illinois. Rotations include technical and non-technical (quality/regulatory) aspects. I also received training in technical and professional areas.First Rotation: Design for Six Sigma - Validation of software templates - Lean Six Sigma, DMAIC, PDP, and Risk Training - Obtained Green Belt Certification Second Rotation: DHF Remediation in IT Quality Third Rotation: Product Support Team for Infusion Pumps

Two internships at Baxter Healthcare for the summers of 2007 and 2008. Internships specialized in materials and product development of I.V. therapies.