Vlad Shepelev Email & Phone Number

Ormond Beach, Florida, United States

Wilsonville, Oregon, United States

• Administrated all manufacturing processes, fixturing and equipment in the laser welding, laser marking, plasma ball welding, ECG, micro-blast, and EDM departments.• Improved yield and cycle times and reduced waste and defects using Lean Manufacturing principles and SPC.• Performed tooling and fixture design to create repeatable processes and improve operator efficiency.• Applied structured problem-solving techniques (8D, Root Cause Analysis) and quality control tools (Fishbone, 5-Why, Process Maps (Flow Charts), Histograms, Control Charts, Pareto Analysis).• Supported Value Stream functions for multiple departments: Ensuring on-time delivery, Engineering Change Order (ECO/ECN/DCO) review and approval, and production line support.• Utilized DMAIC, Design of Experiments, Lean Six Sigma methodology, and statistical analysis using Minitab to characterize and optimize processes.• Utilized OEE tools to identify and eliminate greatest sources of downtime in production.• Effectively utilized machine capacity, reduced labor costs, and improved run rate of manufacturing areas.• Executed Test Method Validations (Gauge R&R), Capability Studies, Risk Assessments, Engineering Studies, and Control Plans to support validation efforts, drive strategic growth, and characterize special processes.• Performed pFMEA, CAPA, NCMR, CAPA, CAR, and PAR to identify process gaps and improve processes, run rates, and reduce scrap rate.• Programmed and designed inspection tools for OGP and Keyence Instance Measuring Microscopes IM-6000, IM-7000 and LM-1000 Series.• Designed and implemented special fixtures for EDM cutting processes; optimized cutting techniques.• Created manufacturing documentations: Process Instructions, Visual Standards, PM, and Inspection procedures.• Served as an internal auditor to ensure conformity with ISO and FDA standards.• Temporarily substituted as engineering manager of metal engineering department.

Tualatin, Oregon

• Developed laser welding applications, designed custom fixtures, and created process recipes for medical grade laser weld products.• Successfully transferred several manufacturing processes from the U.S. to Costa Rica facility.• Provided cost estimation and led projects from tooling/equipment design and prototype development to process validation (IQ, OQ, PQ, PPQ) and manufacturing transfers.• Participated in NPI activities to ensure delivery deadlines and production schedules were met.• Provided feedback and recommended design improvements to customers.• Implemented new argon supplies system that saved over $50,000 annually and reduced laser welding production downtime.• Characterized legacy manufacturing processes to identify full potential and limitations of processes.• Identified and tested new technology to drastically modernize existing processes, increase automation, implement full process monitoring, and increase revenue.• Performed process development on novel equipment platforms and implemented process improvements to conserve costly consumables and design solutions that reduced operator variability.• Performed troubleshooting of equipment and processes and reengineered mechanical components and fixtures.

Portland, Oregon

• Analyzed product design to improve and optimize manufacturing processes at development stage.• Defined, designed, and developed equipment and tooling meeting customers' specifications.• Worked with external vendors to fabricate and implement necessary equipment into production.• Participated in cross-functional and inter-divisional teams by designing and developing new products.• Performed engineering studies for process optimization and analyzed results.• Supported site goals by establishing departmental objectives.• Managed Laser Lab operation and enforced laser safety requirements.• Implemented innovative Laser processing methods, including cutting, etching, and ablation on deep UV and IR lasers in pilot projects using different types of materials.• Developed new operational and assembly instructions and procedures with regards to new products and specifications.• Worked with headquarter regulators to ensure company Laser Safety Policies complied with CDRH, ANZI, and OSHA requirements.

Portland, Oregon

• Processed and handled various materials for manufacturing medical devices and components.• Developed routines and procedures that optimized production operators’ job.• Responsible for original equipment manufacturer (OEM) projects and customers, including custom process development per customers’ specifications.• Provided cost and labor analysis, process documentation, and inspection of all within GMP.• Supported equipment, tooling, and process validations.• Repaired and maintained high cost equipment.• Implemented upgrades improving machines' reliability.• Involved in prototype developments in cooperation with senior engineering level staff.