About Sergey
I'm an independent consultant specialising in medical device software development with 20+ years of experience, including nearly 10 years specifically in regulated medical environments.
I help companies navigate the complex intersection of cutting-edge technology and stringent regulatory requirements. My expertise focuses on secure C++/Qt GUI applications for embedded and desktop systems, as well as connected medical devices, with knowledge and practical experience in applying IEC 62304, ISO 13485, FDA 510(k), and MDR compliance processes.
What I bring to your clients:
- Senior-level C++/Qt expertise from desktop (Windows, macOS X, Debian Linux) to mobile (iOS) to embedded systems (QNX, Yocto).
- Scrum master and software team leader with experience managing off-shore teams.
- Experience helping distributed teams navigate Class II/III device submissions - IEC 62304-compliant development and documentation.
- Cybersecurity assessment experience (SBOM management, UL 2900 certification).
- Cross-functional stakeholder management across regulatory and technical domains.
I can become part of your team, integrating into your processes; or I can provide specific services related to medical device software and documentation, including tools validation and cybersecurity assessment; or I can bring in an experienced team to undertake a whole project development.
English
Native or bilingual
Russian
Native or bilingual
French
Basic
Can work on-site
Charleroi (up to 50km), Brussels (up to 50km), Louvain-la-Neuve (up to 50km), Mons (up to 50km), Antwerp (up to 30km)
Experience
- Mallinckrodt Pharmaceuticals plc / Therakos LLCGUI Subsystem LeadPHARMACEUTICALS INDUSTRYAugust 2024 - April 2025 (8 months)IrelandExtracorporeal photopheresis (ECP) system.• Owned the GUI subsystem, defining requirements with Human Factors, User Experience (UX), Electrical Engineering, and other software teams.• Led an off-site SCRUM team (C++17 / Qt6 on QNX7.1, x86), ensuring on-time deliveries, communication with project teams and stakeholders, daily code reviews, documentation, and UXintegration per IEC 62304-compliant process.• Facilitated migration of Atlassian JIRA projects, Bitbucket repositories, and CI/CD setup from on-premises JetBrains' TeamCity to cloud-based Bitbucket Pipelines amid corporate divestiture.
- Mallinckrodt Pharmaceuticals plcSenior Medical Software ConsultantPHARMACEUTICALS INDUSTRYJune 2023 - August 2024 (1 year and 2 months)IrelandDevice engineering department.• Prepared parts of software documentation for a new inhalable Nitric Oxide delivery system's 510(k) submission, leading to a successful FDA clearance of a Class C medical device in December 2023.• Cybersecurity risk assessments; SBOM management and CVE tracking (Black Duck SCA).• Served as the technical contact for UL2900 certification testing, addressed cybersecurity findings, coordinated communication and logistics across time zones.• Reviewed and refined C++/Qt5 code (QML) for localised interface and features.• Updated Software Architecture & Detailed Design, collaborating with QA and project management.• Recreated build environment for a legacy embedded software in a Docker container and led code reviews for bug fixes in legacy C/C++ code, advising project management as the technical expert.• Performed validation of development tools per regulatory and QA requirements.• Corrective and Preventive Action (CAPA) owner per ISO 13485 process.
- Envista Holdings Corp.Senior Software Engineer, C++/Qt ConsultantMEDICALSeptember 2022 - June 2023 (9 months)BelgiumDental implants and guided surgery planning solutions. Implementation of architectural improvements for a large codebase.• Assisted in successful migration from Qt5 to Qt6 of a complex application (over 500k C++ LOC).• Introduced QML modules for thousands of components, resulting in reduced and clearer dependencies, a significant architecture improvement, enabling more efficient product evolution.• Conducted code reviews and resolved issues to ensure software performance and reliability.
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Education
- Validation & Verification (V&V) Design History File (DHF)Validation & Verification (V&V) Design History File (DHF)