Led engineering projects to bring early-stage medical devices to high-volume manufacturing. Updated device designs and created complex processes to transfer to large scale production. Developed and executed test methods, qualification activities, and validation studies to prove efficacy and yield capacity. • Led engineering projects from initial handoff from client through design iteration, process development, process refinement and qualification, and operator training.• Developed processes leveraging complex catheter technologies to build cutting-edge devices.• Designed components and assemblies to allow specific manufacturing processes including injection molding, over-molding, extrusion, thermal bonding/forming, machining, and coating.• Created fixtures to improve manufacturing consistency and eliminate process/operator error.• Created and released Installation Qualifications, Operational Qualifications, Process Qualifications, work instructions, and engineering drawings for components, assemblies, and equipment.• Presented project updates to clients, with scope including deliverable status, development updates, build plans, and technical deep dives.

Function as engineering lead on multiple projects, overseeing activities encapsulating the design process from initial charter and kickoff through field releaseConduct feedback sessions, performance reviews, and held weekly 1-on-1 meetings in a managerial roleOwn design of specific components within team environment to launch next gen productsConsulted with product management and external physicians to develop user needs Utilized user needs to draft engineering design input requirementsPerform various forms of risk assessments and drafted risk assessment documentation including Risk Assessment Tables, Failure Mode & Effects Analyses, and Design Trace MatricesOwn concept creation and down selection through 3D modeling and prototypingCollaborate with external vendors and firms to design, prototype, ad manufacture componentsCollaborate cross-functionally to organize efforts around production, inspection, and releaseCreate, manage, and release engineering drawingsConduct user feedback sessions with internal and external physicians and subject matter experts, including leading animal lab assessmentsDevelop and execute feasibility tests to exhibit design efficacy and facilitate rapid iterationPresent project updates in various forums including design phase reviews, monthly governance updates, and technical deep divesConduct root cause investigations in project feasibility, pre-DV, and DVAnalyze test data using Excel and Minitab to draw conclusions on design efficacy and root cause investigationsCreate, manage, and release test plans, protocols, and engineering summariesCoordinate and execute Design Verification and Validation testing

Performed failure investigations on complaints returning from the field to find root causePrepared presentations for external sharing of failure investigation findings and reviewed with legal and medical office to approve contentPresented failure investigation results to external physicians via field outreachPerformed data analysis in Excel and Minitab to analyze failure rates, monitor controlled releases, and track product launchedReported out analysis results in weekly meeting forums and in technical deep dive meetingsDocumented failure modes and mitigation methods in external field notifications and internal engineering summariesInvestigated high failure rates through Corrective and Preventative Action (CAPA) methods

Designed test fixtures to simulate clinical trials for advanced development products in a laboratory settingConsulted with doctors and clinicians on viability of test fixtures to ensure the clinical relevance of the designPerformed testing on next generation arterial access devices in both feasibility and validation stagesPerformed data analysis via Excel and MinitabCommunicated testing results and contributed to project decisions in a team environmentCommunicated project results in written summaries and reports

Reviewed building schematics and determined HVAC systemsCollected data from systems and used it to create building profiles Integrated building profiles into fault detection software Commissioned diagnostic results and created reports to be reviewed with clientsOversaw numerous building setup projects, from schematic analysis to diagnostic commissioning, in their entirety

Performed failure analysis on various valve design iterationsDesigned and fabricated test fixtures via SolidWorks and Siemens NXDesigned fixtures to expedite manufacturing processesPerformed tension and compression testing with Instron Tensile Tester and analyzed stress-strain curvesCreated test method to perform thermal analysis on finned preheatersCommunicated testing results in written and oral reports