νκ΅μ΄ README | π Interactive Portfolio β
20+ years leading R&D and platform architecture in safety-critical, ISO-certified domains. Track record spans medical devices, semiconductor EDA, and SaaS platforms β built and certified from zero.
Core Impact:
- Designed SDLC and quality systems compliant with IEC 62304, ISO 13485, ISO 14971 β patterns transfer to ISO 26262, DO-178C, IEC 61508, and ISO 27001
- Led 4 international regulatory approvals (FDA 510(k), CE, KFDA, CCC) with 1,200+ pages of auditor-ready traceability documentation
- Orchestrated 10+ microservices in C++, Rust, Go, Python (RabbitMQ/Redis) at Pozalabs (audio SaaS)
- Achieved 2x throughput and 50% latency reduction on medical imaging systems at Ray
- Built 4+ production systems from blank repo to certified release across 2 IPO companies
Since March 2026, CTO at Flonics β a Seed-stage medical device startup preparing for its Pre-A round β owning development, operations, and management across all projects with a lean team.
π View detailed achievements & projects β
| Metric | Achievement |
|---|---|
| Leadership Experience | 20+ years in R&D and platform architecture |
| Regulatory Certifications | 4 international approvals (FDA, CE, KFDA, CCC) |
| Quality Systems | IEC 62304 (Class B/C), ISO 13485, ISO 14971 SDLC design |
| Distributed Systems | 10+ microservices at Pozalabs (C++, Rust, Go, Python); 2x throughput, 50% latency cut at Ray |
| Documentation Rigor | 1,200+ pages of traceable, auditor-ready SRS/SDS |
| Team Leadership | Led teams of 2-11 engineers; career spans 2 IPO companies (VATECH, Ray β team lead at Ray) |
| Zero-to-One | 4+ production systems built from blank repo to certified release |
| Domain Range | Medical imaging, audio SaaS, semiconductor EDA, system virtualization |
Languages: C++ (14/17), C#, Rust, Go, Python Distributed Systems: Microservices, RabbitMQ, Redis Sentinel, OpenTelemetry, Docker Backend: .NET Core, ASP.NET Web API, PostgreSQL, MySQL, TCP/IP Medical Imaging: PACS, DICOM (C-STORE/C-FIND/C-MOVE), ISO 13485, IEC 62304, HIPAA Cloud & DevOps: AWS, GitHub Actions, zero-downtime deployment UI: WPF (MVVM), Qt/QML
π οΈ Complete tech stack, certifications & specializations β
Medical Device: IEC 62304 (Class B/C), ISO 13485, ISO 14971, FDA 510(k), CE, KFDA, CCC Healthcare Compliance: HIPAA Technical Safeguards, DICOM PS3.15 De-identification
Deep experience in ISO/IEC standard-driven SDLC transfers directly across regulated industries. The standards differ; the discipline β requirements traceability, hazard analysis, V&V evidence, configuration management, post-market surveillance β is the same.
| Capability | Hands-on Standards | Transferable To |
|---|---|---|
| Software Lifecycle | IEC 62304, ISO 13485 | ISO 26262 (Automotive), DO-178C (Aerospace), IEC 61508 (Industrial Functional Safety) |
| Risk Management | ISO 14971, FDA QSR | ARP4761, ISO 27005, IATF 16949 |
| Compliance Documentation | 510(k), CE Technical Files | Type Approval, AS9100, SOC 2, ISO 27001 |
| Audit & Traceability | DICOM PS3.15, HIPAA | GDPR, PCI-DSS, ISMS-P |
CTO at Flonics (since 2026.03) β a Seed-stage medical device startup preparing for its Pre-A round, running lean. Owning development, operations, and management across all projects while leading R&D for medical imaging-based blood flow diagnostics, with ISO 13485 / IEC 62304 processes applied from day one. Maximizing lean-team leverage through an automation-first operation: reporting generated from GitHub issue/PR records, CI/CD test automation, SonarQube security gates, AI code review, and AI-driven triage and reporting of findings β extending to regulated documentation for device certification, verified through human approval gates and automated traceability audits.
Long-term interest: CTO / Head of R&D / Research Director roles in any ISO-certified domain β automotive functional safety, industrial IoT, defense/aerospace, or regulated SaaS. The common thread is building rigorous engineering organizations under standard-driven constraints, not the specific industry vertical.
π§ kcenon@gmail.com πΌ LinkedIn π Interactive Portfolio
Delivering measurable impact through distributed systems architecture and regulatory compliance expertise.