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Process Engineer

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Process Engineer, Інженер з підготовки виробництва, Product owner
Вік:
31 рік
Місто:
Київ

Контактна інформація

Шукач вказав телефон .

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MYKOLA TSARENKO
Kyiv, Ukraine
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PROFESSIONAL SUMMARY
Biomedical Engineer and Process Engineer with strong expertise in patient-specific medical device design and advanced additive manufacturing. Currently working at Materialise and lecturing at the National Technical University of Ukraine (KPI).
Experienced in full-cycle engineering workflows including design, validation, quality control, and process optimization in regulated environments. Proven track record of improving efficiency, developing SOPs, and leading software validation and integration activities.
Specialized in 3D printing technologies for medical and engineering applications, including metal and polymer additive manufacturing (MLS/DMLS, SLS, SLA), with a strong focus on customized implants and surgical solutions.
CORE SKILLS
• Additive Manufacturing (MLS, SLS, SLA)
• Patient-Specific Implant Design
• Design for Additive Manufacturing (DfAM)
• Process Optimization & SOP Development
• Software Validation & Integration
• Risk Management & Regulatory Compliance
• CAD: Mimics, 3-matic, SolidWorks, Rhino, AutoCAD
• Python Automation
• Quality Control & CAPA
• Technical Training & Education
• Azure DevOps

PROFESSIONAL EXPERIENCE
Process Engineer
Materialise — Kyiv, Ukraine
Aug 2024 – Present
• Improved engineering workflows, increasing process efficiency by 20%
• Developed and updated SOPs for titanium implant and surgical guide design
• Led software validation and integration, including protocol development and reporting
• Defined low-level software requirements for system improvements
• Managed Engineering Change Orders (ECOs)
• Conducted patient risk assessments in compliance with regulatory standards
• Developed Python scripts to automate workflows and reduce manual errors
• Delivered internal technical training to engineering teams
• Worked within Agile (Scrum/Kanban) frameworks, using Azure DevOps to manage tasks, track progress, and coordinate cross-functional engineering and software activities

Lecturer (Part-Time)
National Technical University of Ukraine (KPI) — Kyiv, Ukraine
Feb 2025 – Present
• Deliver course on Patient-Specific Design
• Teach implant design and surgical guide development using advanced CAD tools
• Support development of next-generation biomedical engineers

Trainer
Materialise — Kyiv, Ukraine
Aug 2020 – Aug 2024
• Conducted technical interviews and evaluated engineering candidates
• Designed and delivered onboarding and qualification training programs
• Ensured compliance with technical and regulatory standards
• Led complaint investigations and supported CAPA processes
• Organized medical education programs and workshops

Quality Control Engineer
Materialise — Kyiv, Ukraine
Sep 2017 – Aug 2020
• Designed cranio-maxillofacial (CMF) implants
• Developed patient-specific surgical guides
• Performed quality control to ensure compliance with medical and technical standards

Stress Engineer (Intern)
ProgressTech-Ukraine — Kyiv, Ukraine
Feb 2017 – Aug 2017
• Conducted static and fatigue analysis of aircraft structures
• Used numerical methods and engineering simulation tools

EDUCATION
PhD in Biomedical Engineering (Ongoing)
National Technical University of Ukraine (KPI) — Kyiv
2024 – Present
Master’s Degree in Instrumentation Engineering
National Technical University of Ukraine (KPI) — Kyiv
2015 – 2017
Biomedical Engineering Exchange Program
University of Groningen — Netherlands
2016 – 2017
Bachelor’s Degree in Instrumentation Engineering
National Technical University of Ukraine (KPI) — Kyiv
2011 – 2015

ADDITIVE MANUFACTURING EXPERTISE
• Metal 3D Printing: MLS / DMLS (Titanium implants)
• Polymer 3D Printing: SLS, SLA
• Patient-specific implant manufacturing
• Surgical guide production
• Design for Additive Manufacturing (DfAM)
• Post-processing and quality validation
• Workflow optimization and automation
LANGUAGES
• Ukrainian — Native
• English — C1 (Advanced)

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