Atlanta Metropolitan Area
R&D Technical Leader with 18+ years of experience in Medical Device Design, Development, and R&D Strategy. Extensive track record for driving projects from conceptualization to commercial release. Expert in leading cross-functional teams through comprehensive Design Control deliverables, including requirements, risk management (ISO 14971), and Verification & Validation. Strong engineering fundamentals in SolidWorks, FEA, and Statistical Analysis, combined with PMP® certification to execute complex projects aligned with business objectives.
NPD & Commercialization Strategy: Led a New Product Development (NPD) program, partnering with external suppliers for concept design, engineering builds, and functional testing. Managed the feasibility and development phases for a safety-engineered vaccine delivery device, completing the project phases ahead of schedule. Design Control Leadership: Owned the cross-functional execution of design change qualification and Design History File (DHF) remediation for 3 product families (50+ Class II/III products), ensuring compliance with quality standards. Regulatory Project Execution: Led the 510(k) submission and Emergency Use Authorization (EUA) for two syringe product lines to address COVID-19 syringe demands to overcome critical supply shortages. Engineering Problem Solving: Managed 10+ CAPAs from problem identification through root cause analysis to implementation, ensuring corrective actions were effective and compliant. Global Compliance (EU MDR): Managed the EU MDR remediation program for multiple Urology and Critical Care products (Class I, II, III), leading the submission of 9 product families (300+ SKUs) on time. Supply Chain Continuity: Qualified an alternative design and manufacturing site in Europe for spinal anesthesia needles in record time (5 months) following Hurricane Maria, ensuring continued global market supply. Innovation & Process Improvement: Innovated an electronic IFU strategy for a major growth program for Male External Catheters with multi-million-dollar impact that eliminated IFU packing operations, driving significant cost savings and operational efficiency. Project Reporting: Collaborated with senior leadership to align project execution with business priorities, managing collisions, budget, and timelines while providing accurate status reporting.
Team Leadership & Mentoring: Led and mentored a 13-member team focusing on the design and development of disposable medical devices (injection systems) supporting multiple global sites. Managed performance, associate development, and succession planning. Process Innovation & Cost Reduction: Led the qualification of a fully automated insert molding machine for spinal needles across sites in Europe and Mexico. Harmonized designs for interchangeability, resulting in >$1Million annual cost savings by eliminating epoxy components. Verification & Validation (V&V): Developed and executed numerous Design Verification strategies, protocols, and reports. Utilized Minitab for advanced statistical analysis (Capability Analysis, t-test, ANOVA) to justify engineering decisions. Material Qualification: Implemented multiple material qualifications (e.g., Polypropylene resin grades for EU REACH compliance) across 15+ product families, sustaining >$8Millon in annual revenue. Test Method Development: Identified areas for improvement and developed new automated test methods to reduce manual variation and improve testing efficiency (MSA strategies).
Root Cause Analysis: Performed detailed tolerance analysis on critical assembly gaps to identify the root cause of Trocar leakage and proposed effective engineering solutions. Hands-on Engineering: Gained extensive experience in ultrasonic welding; designed aluminum fixtures and assembled 2,000+ components for engineering studies. Functional Testing: Created test methods to mimic end-use cases, performed functional testing on engineering builds, and authored summary reports to support CAPA closures.
Product Design: Designed a low-cost surgical stapler for emerging markets, focusing on device simplification, autoclave sterilization, and Design for Manufacturing (DFM). Finite Element Analysis (FEA): Performed FEA using CosmosWorks to analyze stress and deflection patterns on concept designs, validating results with manual engineering calculations. Tolerance Analysis: Conducted tolerance stack-up analysis for critical assembly gaps in breast biopsy systems. Process Improvement: Standardized drawing creation processes, enhancing quality and efficiency for over 500 drawings.