• Lead on large key deliverable of Test Methods for New Product Integration.• Confirmed that all laboratory tested design requirements have Test Methods linked to them.• Led validation of Test Methods to statistically confirm functionality and repeatability.• Successfully investigated production process in Israel to determine what is tested and how.• When test methods were vague, investigated legacy paperwork and worked with legacy team (some in Israel) to determine original intent.• Determined if equipment was appropriate and capable of testing products• Multitasked to keep multiple projects moving forward simultaneously.• Clearly communicated progress to multiple stakeholders.• Improved and validated Test Methods that did not meet company standards without changing the test’s purpose.• Investigated unexpected results to determine root cause and made appropriate corections.• Worked with multiple departments to develop, qualify, and store fixtures.• Teamed with validation and R&D Engineers to qualify fixtures and testing equipment.• Worked with a cross-functional team of DA, Production, and R&D Engineers, Techs, and Project Managers.• Authored DV Realtime Aging Test Protocol and determined number of samples needed.• Trained technicians on Test Methods and applicable Work Instructions.• Wrote complete Work Instructions on how to operate VICE Cryoablation console and Needles.

• Updated and Improved manufacturing processes. • Observed and worked with operators to learn and document best practices and make improvements.• Trained operators on new procedures and techniques.• Discussed with operators their process concerns and develop improvements.• Updated DMR’s for upcoming new EU MDR resubmittals.• Reviewed new EU MDR labels and updated packaging and final pack Work Instructions.• Verify correct installation and Qualification of production equipment.• Used Six Sigma principles to improve production efficiency • Wrote and verified documentation of production equipment installation.• Watched for and addressed issues that may cause issues for production in the future.

• Led 3rd shift Engineering team in troubleshooting equipment and yield issues on the Tacticath catheter production line.• Successfully worked in a high-pressure, fast-paced roll with high visibility.• Coached operators on how to prevent technique related scrap. • Taught operators how their work relates to the function of the product.• Trained operators on process changes and equipment changes.• Increased yield from 50% to 81%• Solve and communicate yield issues to the team and management.• Use a hands on approach to investigate and solve production issues.• Monitored, managed, and trained operators for special production work requests.• Maintained an in depth knowledge of catheter production processes and was primary resource to the technicians for troubleshooting.• Updated qualification procedures for equipment if incomplete or incorrect.• Worked with cross-functional teams for process, fixture, and tooling improvements.• Assisted Quality Team in investigating CAPA’s causes and solutions.• Worked independently and in a timely manner on weekend shift with little support• Performed IQ’s on new equipment or repaired equipment requalification.

• Authored PFMEA to aid in updating current manufacturing process.• Authored PFMEA’s to accurately understand potential issues during the development phase.• Updated current FMEA template to be more useful for future processes.• Updated previously executed PFMEA’s to include actions taken and proper formatting. • Assisted in designing and developing new manufacturing procedures and fixtures.

• Replicated and began qualifying new production lines.• Wrote new IQ’s from scratch to qualify tools to new standards.• Insured products were being built per process.• Troubleshot issues that arose with new lines.• Updated master validation plan to include new standards.• Aided quality in understanding new documentation standards.

• Tested new process effectiveness.• Authored and executed PQ for new Trimming process.• Authored manufacturing work instructions for using new equipment and processes for product builders. • Performed characterization tests on new thermoforming processes and equipment.• Performed feasibility tests of new equipment for new processes.• Analyzed statistical data with Minitab to determine the reliability of new processes.• Authored and helped execute • Finished required research to test process effectiveness while meeting deadlines.• Performed extensive troubleshooting on processes and machines that did not perform consistently.

• Analyzed production data including yield, process effectiveness, and sudden yield spikes.• Used data to determine process inadequacy work to improve the processes.• Did troubleshooting to solve production issues and increase yield. • Authored and executed multiple IQ's, PCAF's, PPP's.• Authored Work Instructions and trained the product builders.• Assisted in the determination of what utilities were required in the new location.• Moved, installed, and validated manufacturing and testing equipment in a new building.• Unboxed and assembled new equipment for new location.

• Tested new analytic devices to determine effectiveness in manufacturing quality assessment.• Kept detailed notes of initial test expectations and final results.• Analyzed data to determine if new analytic device is reliable.• Completed necessary auditable documentation for all processes and parts I worked on.• Installed new programs for immediate use by production.• Did troubleshooting on parts and programs that were operating incorrectly.

• Advised customers on our products and which would be best for their needs.• Met sales quotas that were needed in order for the company to be profitable.

• Collected and sent defective medical device information to the FDA.• Had in-depth knowledge of the multiple devices and there functionality.• Performed troubleshooting to determine if there was a device malfunction of production error.• Extensive knowledge of multiple CAPA's and their inclusion criteria.• Corrected a processing error that appeared on over a hundred files, protecting the company from failing an FDA audit

• Converted scientific protocols into a functioning computer language for testing.• Made multiple testing programs that were functioning and ready for launch.

• Developed tailored payment plans for delinquent debtors.• Helped clients avoid bankruptcy while still paying back the outstanding debt.

• Assessed disabled students and got them the support and resources needed for school.• Organized all disabled students' medical/disabilities information.

• Sequenced DNA and designed primers for DNA and RNA of various pathogens.• Created eight E. Histolytica primers and two with the potential to identify infection.• Experience working in a Biohazard level 2 environment.