Lead Technician Research And Development Engineering
Waukegan, Il
Performed a broad range of laboratory and customer-facing assignments to support engineering activities from ideation to the successful launch of new medical products. Contributed to the ongoing engineering activities of legacy devices, ensuring their sustained performance throughout the entire product life cycle. Expertise in navigating complex regulatory frameworks while successfully developing, building, and testing medical device prototypes and fixtures.Laboratory Work:• Conceptualized, fabricated, and built proof-of-concepts, prototypes, and unique test fixtures, in strict compliance by adhering to established design control processes, Current Good Manufacturing Practices (cGMP), and good documentation practices within an FDA 21 CFR Part 820 environment. • Developed novel testing methodologies, authored comprehensive lab notebook studies, and conducted innovative experiments not covered by Standard Operating Procedures, Protocols, or any existing documentation. All data generated adhered to a clear objective, method, and concise reporting, resulting in unambiguous conclusions, and delivering reliable and repeatable test results. Customer Facing Role:• Field Service Engineer - 2.5-year project role - ORwell™ Fluid Collection System - Facilitated technology transfer activities from laboratory scale through full commercialization of the ORwell™ 20-liter closed-system collection and disposal system of surgical fluid primarily used in high fluid orthopedic procedures. Conducted in-service training sessions for clinical staff across 26 hospitals nationwide, and actively monitored usage in surgical suites, collaborating with clinicians in real-time during orthopedic procedures.Accomplishment: Reverse Engineering LabImproved lab efficiency and capabilities by modernizing Cardinal Health’s testing and prototyping needs to deduce design features, redocumentation of legacy systems and perform competitor analysis.
