Responsible for daily production throughput and resolving issues.● Served as New Product Introduction (NPI) engineer on design and documentation of cannulae used on left ventricular pump and innovative 3-D right ventricular access pump. - Co-inventor of 3-D right ventricular access catheter (patent pending).- Led manufacturing effort that reduced cannula build from 7-day, 65% yield to 3-day, greater than 90% yield.- Reduced cannula build time from 9-day, 35% yield to 3-day, > 85% yield by leading process and fixturing effort ● Designed, documented and procured cleanroom fixtures (manual and semi-automated) which simplified manufacturing, improved product quality, and provided scalability using Solidworks with ISO formatted drawings.- Worked closely with vendors to help understanding and interpretation of ISO drawings.● Procured and validated dispensing and coiling machines utilizing single minute exchange dies (SMED), making single style of equipment multi-functional with minimal change-over time.- Eliminated need for design, purchase and use of valuable floor space of single function machines.- Served as lead engineer on machine CE certification for sister plant in Germany.- Designed, documented and validated high precision mandrels for use on dispensing machine.- Eleven global multifunctional machines purchased.● Team lead in root cause analysis of assembly failures.● Wrote and updated production work instructions and article specifications; utilized heavy use of pictures with minimal verbiage, providing easy to follow documents for multi-cultural production associates.● Resolved reverse osmosis water system issues for parts cleaning department.- Documented, and validated sanitary method of filling ultrasonic cleaners from single point-of-use.- Provided system maintenance and contact point for company.● Provided engineers and co-ops with one-on-one mentoring in fixture and equipment design, documentation, and presentations

Manufacturing engineer of R&D team that developed next generation radiation therapy delivery catheter (MammoSite Multilumen, 4-5 cm) involving injection-molded parts, extruded components, and assembly of components. Provided input on design for manufacturing (DfM), wrote all assembly procedures and routers, and designed lean line layout.• Performed DfM on product prior to release for design verification (DV) builds. Examples: adhesive types reduced from seven to two, rigid section redesign incorporating alignment notches, and enhanced hub design.• Designed lean production line for prototyping and DV unit builds which was carried through production.• Led design, fabrication, and qualifications of fixtures used in process which stabilized assembly and vetted out units with issues. Oversaw transfer of product lines to Costa Rica manufacturing facility.● Performed process validation of radiation therapy delivery catheter (MammoSite II IP, 5-6cm).● Delivered into production successful product line while optimizing product quality with critical in-line inspection points.● Performed equipment and fixture IQ, OQ, and PQ’s including protocols, data analysis, and final reports. ● Redesigned packaging tools (SMED) and equipment including qualification which improved quality of packaging.● Transferred and validated product lines (both I-to-E and I-to-I), performed root cause analysis on sterilization issues, and served as project engineer on factory qualification and transfer of steam sterilizer to Costa Rica.

Developed new function within instrumentation product development Product Evaluation Group to provide statistical and real-time analysis on reliability of components, subassemblies, and full instruments. • Determined error allocations (or error budgets) to establish reliability goals.• Prepared protocols, identified, performed, and supervised required testing, and prepared reliability reports.• Performed statistical test design including mean-time-between-failure (MTBF) or mean-time-to-failure (MTTF) determination using Weibull analysis for confirmation of success or recommendations for improvement.- Led reliability and corrective action teams to resolve emerging field issues.• Proposed instrument maintenance enhancements from comprehensive testing programs that minimized field service calls. • Calls per year decreased by 17 per system resulting in savings of $35,000 per system per year.• Key engineer on field return reviews, analysis, and trending leading to improvements in manufacturing.• Provided design testing options and assistance to engineers for selection of components.