• Design, create, and publish physical media via KDP using digital design software.• Manage all aspects of Product Development and Product Engineering from concept to sale, ensuring top-quality products.• Customer Analytics and market research.• Generative AI expertise, including prompt engineering and creation of text and images.

• Manage Design Verification activities for combination drug products utilizing the SmartDose 10 OBDS injection and containment platform.• Execute Design planning, risk assessment, design reviews, preparation of technical protocols, reports and other design documentation to support pharmeceutical customer clinical drug trials.

• New Product Development (NPD) Engineering: Lead NPD R&D Engineer on cross-functional teams to develop and launch 5 unique vascular products through design verification and validation for US FDA Class II device clearance, including Steerable Introducers, Transseptal Needle, ICE Catheters, and Mapping Catheters. • Product Quality: Completed FMEA, MSA, GR&R, and validations. Directed root cause analysis (RCA) on 15+ device, test, and process failures. Applied Design of Experiments (DOE) to product testing and analyzed statistical data analysis in Minitab.• Supplier Qualification: Collaborated with Global Quality Organization to execute Production Part Approval Process (PPAP) on new supplier components. Negotiated deliverables, certifications, and completed First Article Inspections (FAI) on delivered product. • Process Improvement: Slashed 18 months off manufacturing material lead time by driving continuous quality improvement and Design for Manufacturing principles into sustaining engineering design, preventing $300k in revenue loss on introducer sheathe line. • Regulatory Compliance: Proficient in project execution to Quality Management Systems (QMS), design controls, and risk management requirements as specified in ISO 13485, 21 CFR 820, ISO 14971, and FDA regulations for medical devices.• Engineering Leadership: - Technical Strategy Working Group - Technical Review Board (TRB) - SME – Polymer Materials - SME – ASTM F1980-21 Accelerated Aging - SME – ISO 10993-1 Biocompatibility - SME – ISO 10555-1: Intravascular Catheters

• Composites/Non-metallic materials and processes engineering. Subject Matter Expert (SME) and lead engineer at Boeing Mesa for all paints, coatings, abrasives, and solvents, and related processes across 4 aircraft programs.• Expert in large-scale surface preparation processes, including sanding, media blasting, chemical stripping, and solvent cleaning.• Global Manufacturing Transfer: Coordinated chemical technology process transition from the US to suppliers in India, increasing production capacity of critical components by 50%.• Project Management: Overachieved metrics as an engineering project manager certified in Earned Value Management by employing Project Management tools (Six Sigma, Gantt, Kanban, Microsoft applications) with 100% customer satisfaction. • Authored and maintained 40+ technical specifications for materials and production processes across the Boeing enterprise.• Experienced handling high-pressure engineering situations like large scale failure analyses, production line stoppages, supplier quality issues, and government customer or regulatory body interactions.

• Responsible for 737 and 787 chrome-free primer material and process specifications, including production line support and new material qualification testing.• Developed novel 737 MAX winglet erosion prevention glove paint process and managed the program through technical gate reviews and executive briefs.• Identified areas of opportunity in aircraft production/assembly operations and reduced overall processing time in targeted cells by 25%.

• Developed, scaled, and implemented chromium-free primer and water-based topcoat processes on all new-build AH-64 Apache helicopters produced by Boeing.•Experienced with the mechanisms, testing, and control of corrosion on aluminum and steel.• Specified recertification test requirements for manufacturing materials, including paints, tapes, and adhesives for incoming receipt and shelf life extension.• Mechanical Testing: Executed a gamut of mechanical lab tests on metallic and composite materials in the materials test laboratory (lap shear, fatigue, creep, 3-point bend, tensile, compression, T-peel, etc.).• Maintained specifications and QPL’s for nonmetallic materials and processes. Performed process conformity surveys/audits at over 50 external supplier facilities across the country.

• Created Instron test frame protocols and executed mechanical testing on polymer materials and adhesive bonded joints. Trained new engineers on laboratory test equipment.