11.03.2026 aktualisiert

**** ******** ****
100 % verfügbar

Senior Embedded Software Engineer | MedTech | Zephyr OS | IEC 62304 | Cybersecurity

Mannheim, Deutschland
Weltweit
Dipl.-Ing. (FH) Technische Informatik
Mannheim, Deutschland
Weltweit
Dipl.-Ing. (FH) Technische Informatik

Profilanlagen

CV_Florian_Kubala_ENG_20260202.pdf

Über mich

Als Freelance Embedded Software Engineer mit über 15 Jahren Erfahrung entwickle ich robuste Softwarelösungen für die Medizintechnik und sicherheitskritische Bereiche. Mein Fokus liegt dort, wo hohe regulatorische Anforderungen auf komplexe technische Herausforderungen treffen.

Skills

Agile MethodologieARM ArchitekturMedizinische GeräteAtlassian ConfluenceAtlassian JiraTest AutomationUnit TestingBluetooth Low EnergyBluetoothC++CmakeCodeanalyseCompilerProfilingProtocol StackComplianceInformationssicherheitContinuous IntegrationDebuggingEclipseEmbedded SoftwareEthernetHalbleiterFreertosFunktionale SicherheitIec 62304Iso 13485ISO 14971PythonMisra CSicherheit bei Drahtlosen VerbindungenNunitPerforceX.509ScrumSoftware ArchitectureQualitätsmanagementEchtzeit-BetriebssystemeSchreiben von DokumentationRequirements EngineeringScaled Agile FrameworkSichere CodierungSniffersSubversionTCP / IPUartUMLVisual Studio OnlineWindchillDrahtlose KommunikationScriptingTestenPicmicroPTC WindchillInternet Of ThingsGitC11V-modellGnu-BetriebssystemRegulatory AffairsTeamcityRisikomanagementSoftware Version ControlJenkins
SCHWERPUNKTE
  1. Embedded Software Engineering (Medical Devices & Safety-Critical Systems)
  2. Functional Safety
  3. Cybersecurity
  4. Wireless Connectivity
  5. System Modernization
  6. Low Power Optimization
ZERTIFIZIERUNGEN
  1. Certified Professional for Software Architecture - Foundation Level (CPSA-F, 2024)
  2. Certified Professional for Medical Software - Foundation Level (CPMS, 2022)
  3. Safety Expert Active Medical Devices (TÜV Süd, 2017)
PROGRAMMIERSPRACHEN & OS
  1. C (C99, C11, C18) inkl. MISRA C Konformität
  2. C++
  3. Python (Scripting & Test Automation)
  4. RTOS: Zephyr OS, Bare Metal Development
REGULATORIK & STANDARDS (MEDICAL)
  1. IEC 62304 (Software Life Cycle)
  2. ISO 14971 (Risk Management)
  3. IEC 60601-1
  4. Quality Management: ISO 13485, FDA QSR (21 CFR Part 820)
  5. Regulatory Affairs: EU MDR / IVDR Support
  6. Cybersecurity: Security Implementation, Penetration Test Support, X.509 Certificates, AES Encryption
MICROCONTROLLER (SCHWERPUNKT ARM CORTEX-M)
Fundierte Entwicklungserfahrung auf ARM Cortex-M (M0, M0+, M4, M33) über diverse Hersteller hinweg:
  1. Nordic Semiconductor: nRF51, nRF52 Series (BLE SoCs)
  2. STMicroelectronics: STM32 (STM32WB, STM32U0, L-Series)
  3. Texas Instruments: ARM Cortex & MSP430 (16-bit Low Power)
  4. Microchip: ARM Cortex & AVR/PIC
KOMMUNIKATION & PROTOKOLLE
  1. Wireless: Bluetooth Low Energy (BLE) Protocol Stack, Generic Attributes (GATT), Custom Profiles & Services, ACS, IDS, CMGS, DTS, Interoperability Testing (IOP), Standardization, PTS Testing
  2. Wired Interfaces: SPI, I2C, UART/USART, Ethernet (TCP/IP, UDP)
TOOLS & ENTWICKLUNGSUMGEBUNG
  1. IDE/Compiler: IAR Embedded Workbench, GCC (GNU Toolchain), VS Code, Eclipse, CMake
  2. Debugging: J-Link, JTAG/SWD, Logic Analyzers, Oscilloscopes, Nordic Power Profiler Kit, Sodera Bluetooth Sniffer
  3. Version Control: Git, SVN (Subversion), Perforce
QUALITÄTSSICHERUNG & TESTING
  1. Static Code Analysis: Klocwork
  2. Unit Testing & Coverage: VectorCAST, NUnit
  3. CI/CD: Jenkins, TeamCity
DOKUMENTATION & ALM
  1. Tools: Sparx Enterprise Architect (UML), Windchill (PTC Integrity/RV&S), JIRA, Confluence, Crucible
  2. Dokumentation: Software Requirement Specification (SRS), Software Architecture Design (SAD), Software Detailed Design (SDD), Verification Plans & Reports
METHODIKEN
  1. Agile Software Development (SAFe, Scrum)
  2. V-Modell
  3. Requirements Engineering

Sprachen

DeutschMutterspracheEnglischverhandlungssicher

Projekthistorie

Embedded Systems Architect – Feasibility Study (Zephyr RTOS)

Pharma und Medizintechnik

>10.000 Mitarbeiter

  1. Designed the migration path from a proprietary OS to Zephyr RTOS for an STM32WB55 based system.
  2. Implemented a C/C++ Proof of Concept (PoC) to verify feasibility, real-time behavior, and memory usage on target hardware.
  3. Defined software interfaces and adaptation layers to maintain compatibility with legacy test frameworks.
  4. Provided a comprehensive technical report and detailed effort estimation, clarifying technical hurdles prior to full-scale development.

Senior Embedded Software Engineer | Medical Devices & Cybersecurity

Roche Diabetes Care GmbH

Pharma und Medizintechnik

>10.000 Mitarbeiter

Full-lifecycle development of safety-critical software (IEC 62304 Class C) for insulin pumps and CGM systems. Focus on connectivity, cybersecurity, and hardware-near development in a highly regulated environment (FDA, MDR).

Key Responsibilities & Achievements:
  1. Cybersecurity & Connectivity: Implemented an IAM framework (X.509, AES) for secure BLE interoperability. Provided technical support for penetration tests (Fraunhofer SIT) and managed Bluetooth qualification (PTS) and standardization (IDS/ACS/CGMS profiles).
  2. System Modernization: Ported firmware from legacy MCUs (TI MSP430) to modern ARM platforms (STM32U0, Nordic nRF52) and integrated 3rd-party software on nRF51 SoCs (incl. vendor management).
  3. Regulatory Compliance: Created technical documentation for FDA premarket submissions and CE marking. Ensured full compliance with IEC 62304 and ISO 13485 standards.

Tech Stack: C/C++ (C11/18), ARM Cortex-M, Nordic nRF52/nRF51, STM32U0, TI MSP430, Bluetooth Low Energy (BLE), Cybersecurity (AES, X.509), IEC 62304, ISO 13485, VectorCAST, Enterprise Architect.

Development Engineer – Light Rail Vehicles

Bombardier Transportation GmbH

Automobil und Fahrzeugbau

>10.000 Mitarbeiter

Development and validation of vehicle control software for light rail vehicles (trams), covering the complete software lifecycle from requirements to commissioning.

Key Responsibilities:
  1. Software Development: Designed and implemented control logic for vehicle control units, primarily using IEC 61131.
  2. Full Lifecycle: Conducted requirements analysis, software design, and unit testing according to V-Model methodologies.
  3. System Integration: Supported software integration and testing directly on the vehicle.
Tech Stack: IEC 61131, PLC Programming, Vehicle Control Units (VCU), Safety-Critical Systems, V-Model.

Embedded Software Engineer | Automotive (AUTOSAR)

Fujitsu Semiconductor Europe GmbH

Internet und Informationstechnologie

5000-10.000 Mitarbeiter

Development and documentation of automotive software components according to AUTOSAR standards. Covered the complete software development lifecycle from specification to system integration.

Key Responsibilities:
AUTOSAR Development: Designed and implemented software components in C, adhering to strict automotive methodologies.
Full Lifecycle: Managed specification, detailed design, implementation, and testing of embedded modules.
Integration: Performed software integration and verification ensuring system stability.

Tech Stack: C, AUTOSAR, Automotive Electronics, Embedded Systems, Software Design.


Zertifikate

Certified Professional for Software Architecture

iSQI GmbH

2024

Certified Professional for Medical Software

Certible GmbH

2022


Kontaktanfrage

Einloggen & anfragen.

Das Kontaktformular ist nur für eingeloggte Nutzer verfügbar.

RegistrierenAnmelden