Florian Kubala
Embedded Software Engineer (Medical Devices)
Experience
Embedded Software Engineer (Medical Device)
Freelance
- Designed the migration path from a proprietary OS to Zephyr RTOS for an STM32WB55 based system.
- Implemented a Proof of Concept (PoC) firmware to verify feasibility, real-time behavior, and memory usage on target hardware.
- Defined software interfaces and adaptation layers to maintain compatibility with legacy test frameworks.
- Provided a comprehensive technical report and detailed effort estimation, clarifying technical hurdles prior to full-scale development.
Senior Embedded Software Engineer
Roche Diabetes Care GmbH
- Executed the full software development lifecycle (concept to V&V) for Class IIb medical device software, adhering to IEC 62304 Class C, and applied architectural segregation to decouple safety-critical functions from Class B domains.
- Designed and implemented a serial interface to integrate third-party OTS/SOUP software with the nRF51 MCU, managing reliable data exchange.
- Managed supplier communications regarding changes and bug fixes, providing active support during integration testing against the peer device.
- Developed custom firmware for the nRF52 platform (Nordic SDK) to replace legacy OTS software, ensuring a seamless transition during nRF51 hardware migration.
- Supported component selection and software porting for the transition from a 16-bit TI MSP430 MCU to a modern STM32U0 architecture.
- Integrated an SPI-interfaced micropower differential angle sensor to enhance stepper motor control precision for accurate insulin delivery.
- Integrated the Bluetooth Authorization Control Service (ACS) using X.509 certificates and AES-application-layer encryption to ensure secure device-to-phone telemetry and plug & play interoperability for Automated Insulin Delivery devices.
- Provided comprehensive support during cybersecurity assessments (including penetration testing) by supplying test devices, documentation, and participating in remediation discussions, contributing to successful attestation by the Fraunhofer Institute for Secure Information Technology.
- Contributed technical documentation and support for FDA premarket submissions, CE marking technical files, and IECEE CB Scheme reports.
- Participated in Bluetooth Low Energy standardization for Insulin Delivery Service (IDS) and Authorization Control Service (ACS) by engaging in technical discussions, developing prototypes, and executing interoperability tests.
- Performed BLE qualification tests using the Profile Tuning Suite (PTS), documented rationales for waivers/deviations, and served as the technical liaison with the qualification consultant.
Development Engineer – Light Rail Vehicles
Bombardier Transportation GmbH
- Conducted requirements analysis, design, implementation, and testing of vehicle control software, primarily in IEC 61131.
Embedded Software Engineer
Fujitsu Semiconductor Europe GmbH
- Developed and documented automotive software components according to AUTOSAR methodologies, covering the entire lifecycle from specification and design through implementation, integration, and testing.
Summary
Highly motivated and results-oriented Freelance Embedded Software Engineer with 15 years of experience. More than 10 years of experience specializing in the development of safety-critical software (IEC 62304 Class C) for Class IIb medical devices, ensuring Functional Safety and compliance (ISO
- Proven ability to deliver robust solutions from concept through V&V and market release, with key expertise in Cybersecurity, Bluetooth LE connectivity, and Low Power optimization.
Seeking challenging freelance projects in the MedTech industry requiring deep technical expertise and regulatory adherence.
Skills
- Programming Languages: C (C99/c11/c18, Misra C:2023), C++, Python
- Microcontrollers: Arm Cortex-m (M0, M0+, M4) With Extensive Development Experience Across Platforms From Nordic Semiconductor, Stmicroelectronics (Stm32), Microchip And Texas Instruments; Texas Instruments Msp430 With Experience On This Low-power Architecture
- Medical Device Standards & Regulations: Iec 62304, Iso 13485, Iso 14971, Iec 60601-1, Fda Qsr (21 Cfr Part 820), Eu Mdr/ivdr
- Development Tools & Ides: Iar Embedded Workbench, Gcc, Cmake, Vs Code, Eclipse, J-link
- Version Control: Perforce, Git, Svn
- Communication Protocols: Bluetooth/ble, Spi, Uart, I2c, Ethernet (Tcp/ip, Udp)
- Hardware & Debugging: Logic Analyzers, Jtag/swd Debugging, Bluetooth Sniffer, Oscilloscopes, Nordic Power Profiler Kit
- Methodologies: Agile (Safe), V-model, Waterfall
- Documentation: Requirements Engineering (Srs), Software Architecture (Sad), Detailed Design (Sdd), Verification Plans & Reports, Risk Management File (Rmf) Contributions
- Development And Documentation Tools: Sparx Enterprise Architect, Windchill (Ptc, Rv&s), Vectorcast, Klocwork, Jira, Confluence, Crucible, Ci/cd (Teamcity, Jenkins), Nunit
Languages
Education
Mittelhessen University of Applied Sciences
Diploma Engineer (FH) · Computer Engineering · Friedberg, Germany · 1.2
Avaya-Tenovis GmbH & Co. KG
IT Specialist in System Integration · Frankfurt, Germany
Certifications & licenses
Certified Professional For Software Architecture – Foundation Level
Certified Professional For Medical Software - Foundation Level
Safety Expert Active Medical Devices
TÜV
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