09/23/2025 updated

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Principal C++/Qt Engineer | 20+ yrs | Embedded & GUI Lead | Medical Devices | IEC 62304, ISO 13485

Beaumont, Belgium
Worldwide
Beaumont, Belgium
Worldwide

Profile attachments

Sergey_Eliseev_CV.pdf

About me

Team Lead, Product Owner, C++/Qt Engineer with 20+ yrs in embedded and GUI software, 12 as consultant. Specialized in medical devices, IEC 62304, ISO 13485, FDA 510(k). Led teams on QNX, Linux, ARM; expert in Qt/QML, C++, cybersecurity, CI/CD. Proven track record in certification and compliance.

JavaScriptAgile MethodologyApple IOSApple Mac SystemsC Sharp (Programming Language)C++ (Programming Language)Computer SecurityComputer ProgrammingDebian LinuxLinuxEmbedded CEmbedded SystemsMedical SoftwareIEC 62304ISO 13485Python (Programming Language)QNX (Software)Scrum MethodologyQt Modeling Language (QML)Qt (Software)Real-Time Operating SystemsRisk AnalysisSecurity AnalysisSoftware EngineeringOperations and Management PlatformSwift (Programming Language)Cyber Threat AnalysisTeam ManagementDocker
C++ Programming
Modern C++17 development with extensive experience in embedded systems and cross-platform applications spanning over 20 years of professional software development.

Qt Framework
Qt and QML framework expertise for developing embedded, desktop, and mobile GUI applications with implementation experience across multiple platforms.

Medical Software Compliance
Expertise in IEC 62304, ISO 13485, FDA 510(k), and MDR-compliant processes for medical device software development and certification.

Cross-Platform Development
Experience with multiple platforms including Embedded/RTOS (Linux, QNX), desktop (MS Windows, macOS, Debian) and iOS.

Agile Leadership
Technical team leadership with Scrum mastery and agile coaching experience for improving team collaboration and software processes.

Multi-language Programming
Proficiency in Embedded C, Python, JavaScript, Swift, and C# alongside core C++ expertise.

Cybersecurity
Cybersecurity risk assessments, SBOM management, CVE tracking, and security analysis for medical device software.
 

Experience

Professional experience10+ years
Freelancer since2012

Languages

EnglishFluentRussianNative speaker

Project history

Team Lead | Medical Devices

Therakos LLC

Pharmaceuticals & Medical Technology

50-250 team member

Led GUI subsystem delivery (Qt6/C++17 on QNX 7.1/x86) for a next-gen extracorporeal medical device, acting as Product Owner and architecture lead:
  • Defined and maintained IEC 62304-compliant workflows; captured GUI requirements via cross-functional coordination with UX, Human Factors, Systems, and EE teams.
  • Managed 6 remote developers and 3 UX designers; translated Figma designs into 200+ user stories, driving delivery through full Scrum lifecycle.
  • Cut infrastructure costs by ~€30k by migrating on-prem CI/CD toolchain to Bitbucket Pipelines.
  • Authored Software Architecture and Detailed Design documentation; led architectural reviews and tool validation for SDLC compliance.

Principal Software Engineer | Medical Devices

Mallinckrodt Pharmaceuticals plc

Pharmaceuticals & Medical Technology

500-1000 team member

Helping an organization to get through red tape for medical device certification:
  • Supported a successful FDA 510(k) clearance for a Class C system by analyzing legacy code and documentation to respond to regulator queries on connectivity and cybersecurity.
  • Updated Software Architecture and Design documentation (SAS, SDD) and provided timely technical input that enabled on-schedule submission.
  • Led generation of the Software Bill of Materials (SBOM) in CycloneDX format and conducted component-level cybersecurity analysis using Black Duck SCA.
  • Acted as the technical lead for UL 2900 re-certification: coordinated international logistics, set up secure test environments, and addressed test findings across time zones.
  • Refactored and containerized a legacy embedded Linux build environment in Docker, integrated it into TeamCity CI pipelines, and enabled external engineering teams to deliver critical changes.
  • Oversaw GUI internationalization efforts, reviewing code changes by an external team; implemented and documented critical updates to meet regional compliance requirements.
  • Performed software tool validation under IEC 62304; owned closure of a CAPA as part of ISO 13485 compliance efforts.

Senior Software Engineer | Medical Software

Envista Holdings Corp.

Pharmaceuticals & Medical Technology

500-1000 team member

Modernized cross-platform desktop dental software suite (>500k C++ LOC) during Qt5 to Qt6 migration:
  • Resolved Qt6 compatibility issues and cleaned up platform-specific regressions.
  • Built a QML module migration script that improved conversion efficiency by ~30%.
  • Reviewed peer code to ensure performance and maintainability.

Cybersecurity Analyst | Medical Devices

Artidis

Pharmaceuticals & Medical Technology

50-250 team member

Cybersecurity analysis and threat assessment of the software subsystem of a medical device with software stack based on Debian Linux. Authored documents for FDA submission.

Senior Software Engineer | Medical Devices

Phillips-Medisize

Pharmaceuticals & Medical Technology

500-1000 team member

Design, implementation and documentation of a new generation smart auto-injector device software:
  • Architectural design for components of a Class C embedded medical device.
  • Design documentation authoring and reviews according to IEC 62304 standard.
  • Software implementation for an ARM Cortex-M4 -based CPU (embedded C99 and C++14).
  • Front-end GUI implementation using TouchGFX library.

Senior Software Engineer | Medical Devices

Cochlear Ltd.

Pharmaceuticals & Medical Technology

1000-5000 team member

As a lead GUI developer, implemented and guided through regulatory approval surgery assistance application for real-time feedback during cochlear implant insertion surgeries using BLE communication.
  • Cross-platform application released for iPadOs in Apple Store.
  • GUI developed in QML with backend in C++17 and Qt5.
  • IEC 62304 compliance; TÜV and FDA approved.
  • Bridged C++ libraries to Apple Swift 5.3 for use in native applications.

Software Architect, Consultant

Flytek Belgium SPRL

Industry & Mechanical Engineering

< 10 team member

Architecture of a GUI application managing complex hardware installations. Leading off-site team of developers for project implementation.

Senior Software Engineer | Medical Software

Nobel Biocare AG

Pharmaceuticals & Medical Technology

500-1000 team member

Development of a new dental practice application suite DTX Studio Clinic for patient imaging data management and dental diagnostics:
  • Implemented cross-platform desktop GUI components in QML and QWidgets.
  • REST API client-side implementation and JSON serialization library in C++.
  • Dropbox-like file synchronization system.

Senior Software Engineer | Agile Coach

IBA (Ion Beam Applications S.A.)

Pharmaceuticals & Medical Technology

500-1000 team member

Improved software process of a team of research engineers working on a patient positioning verification software for proton therapy complex:
  • Conducted C++11 and Qt5 training with follow-up to ensure practical application.
  • Established code review process based on Phabricator platform; administered Phabricator instance and gave direct training for users and administrators.
  • Agile coaching on SCRUM practices to improve team collaboration.

Senior Software Engineer | Medical Software

Nobel Biocare AG

Pharmaceuticals & Medical Technology

500-1000 team member

Developed components of 3D maxillofacial surgery planning and dental implant planning software products using C++ and Qt framework:
  • Created graphical and computational software components.
  • Provided QML training and created the department’s QML best practices.
  • Created programming guidelines for high-DPI screens.
  • Contributed to the software process for improved code quality.

Senior Software Engineer | C++/Qt Consultant

Nalys Sprl

Industry & Mechanical Engineering

50-250 team member

Qt GUI applications for industrial products:
- Creating Qt5 environment in a Yocto-based platform.
- Provided Qt5 and QML training.

Senior Software Engineer | GUI Lead

Tein Technology S.A.

Telecommunications

50-250 team member

Implemented GUI and backend of a multiline voice phone prototype for an infrastructure project.

Senior Software Engineer | Qt Consultant

I-Optics B.V.

Pharmaceuticals & Medical Technology

50-250 team member

Developer components of a Qt GUI application in a medical device.

Software Engineer

Nokia Oyj

Telecommunications

>10.000 team member

Embedded C, C++, Python, C# and Qt-based R&D tools for Nokia Series 40 GSM phone software.

Software Engineer, Qt Consultant

Laerdal Medical

Pharmaceuticals & Medical Technology

250-500 team member

Developed a component for Qt GUI application on an embedded device.

Software Engineer

Elektrobit Plc

Telecommunications

500-1000 team member

  • Windows desktop applications.
  • GSM protocols decoding libraries.
  • Embedded development for mobile NFC system.
  • Device driver development for an HSDPA modem.

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