David Chtchavlinski Email & Phone Number

Sarasota, Florida, United States

Stenløse, Capital Region, Denmark

• Successfully managed the overseas transfer of manufacturing of catheter technology (Class II device), including planning and leading cross-functional team, resulting in new product lots to stock.• Implemented manufacturing processes such as thermal and adhesive bonding, packaging, labeling, sterilization, quality control. Performed risk assessments and executed process qualifications. Developed, validated, and executed test methods in accordance with ISO and ASTM standards.• Performed design changes and reviews according to customer input from Clinical and Marketing team and feedback from suppliers. Led process changes as part of continuous improvement efforts.• Created production bills of materials, performed production planning and material procurement, trained production operators, maintained production equipment and environment, performed root cause analysis, and participated in CAPA and NC investigations and closures.• Remediated and updated procedures for production, equipment management, and environmental controls, in compliance with FDA Good Manufacturing Practices and MDR regulations. Supported as manufacturing lead in internal and external Quality and Environmental Management System audits under ISO 13485 and ISO 14001.• Supported Regulatory with technical documentation for product CE filing under MDR.

Sarasota, Florida, United States

• Applied design controls to lead the design transfer of acquired catheter technology (Class II device) including remediation of the Design History File, implementation of labeling design changes, and onboarding of suppliers.• Created engineering drawings of concepts and prototypes. Developed strong familiarity with processing of thermoplastics and laser cutting, annealing, and electropolishing of Nitinol material.• Contributed to Sales and Marketing initiatives by supplying technical information for new marketing brochures and material.• Led successful and on-time update and requalification of ISO Class 8 cleanroom environment.• Supported development of the Quality Management System, including transition to eQMS and authoring required SOPs, work instructions, forms, and policies.

Sarasota, Florida Area

• Developed new medical devices for the dental industry (Class I devices) by creating proof of concepts through use of CAD, 3D printing, and machining, material selection, and bench testing.• Created lab test methods, tooling, and fixtures and performed design verification testing.• Worked with manufacturing to improve and validate production equipment, including conducting software and equipment validation activities.

Orlando, Florida Area

• Designed next generation wind turbines by collaborating with engineering, production, field service, and vendors, to meet product design requirements, implement cost-out measures, and to conduct design FMEAs, reviews, and testing.• Used CAD to design sheet metal, welded, and machined parts per ISO, EN, and ASME standards, working with complex assemblies including structural, electrical, and hydraulic assemblies.

Orlando, Florida Area

• Supported the Technical Project Management team within Region Americas new units• Function as lead for compiling regional documentation and tracking technical project deliverables• Assist in process improvement and maintaining the internal databases

Bachelor’S Degree, Mechanical Engineering

Associate Of Arts (A.A.)