EMBEDDED SOFTWARE

The Code that drives our world.

For over a decade, my focus has been on developing safety-critical software for medical devices. In doing so, I not only ensure functional safety but also full compliance with crucial standards such as IEC 62304 and ISO 13485. My proven track record includes successfully delivering robust solutions from conception through verification and validation (V&V) to successful market launch. This ranges from developing innovative firmware for diagnostic devices to implementing secure communication protocols for therapeutic devices that are in daily use.

My expertise also extends to essential areas such as cybersecurity to protect your products from threats, Bluetooth LE Connectivity for seamless and energy-efficient wireless communication, and low-power optimization to maximize the battery life of your devices – crucial factors for the competitiveness of today’s products.

I am actively seeking new, challenging freelance projects, ideally in the MedTech industry but not limited to it, that require a unique combination of deep technical know-how and a solid understanding of regulatory frameworks. If you need support with complex embedded challenges or have a project where precision and safety are top priorities, I look forward to connecting with you and discussing how I can strengthen your team.

• Programming Languages:
  • C (C99/C11/C18, MISRA C:2023)
  • C++, Python
• Microcontrollers:
  • ARM Cortex-M (M0, M0+, M4): Extensive development experience across platforms (Nordic Semiconductor, STMicroelectronics – STM32, Microchip, Texas Instruments).
  • Texas Instruments MSP430
• Hardware & Debugging:
  • Proficient with Logic Analyzers, JTAG/SWD Debugging, Bluetooth Sniffers, Oscilloscopes, Nordic Power Profiler Kit.
• System Integration:
  • Proven ability to integrate third-party OTS/SOUP software, manage supplier communications, and support integration testing (e.g., serial inter-processor communication).
  • Experience with hardware/software modernization efforts, including custom firmware development for new platforms (nRF52) and MCU transitions (MSP430 to STM32U0).

• Communication Protocols:
  • Bluetooth/BLE (including IDS & ACS standardization, qualification, and IOP testing).
  • SPI, UART, I2C, Ethernet (TCP/IP, UDP).

• Cybersecurity Implementation:
  • Integrated Bluetooth Authorization Control Service (ACS) using X.509 certificates and AES-based encryption within Identity and Access Management (IAM) framework.
  • Ensured Secure Plug & Play Interoperability for Automated Insulin Delivery (AID) devices.
• Cybersecurity Assurance:
  • Supported comprehensive Cybersecurity Assessments (including Penetration Testing by Fraunhofer SIT), contributing to successful attestations.

• Standards & Regulations: Knowledge and application of:
  • IEC 62304 (Medical Device Software Lifecycle)
  • ISO 13485 (Quality Management Systems)
  • IEC 60601-1 (Medical Electrical Equipment Safety)
• Certifications:
  • Certified Professional for Medical Software – Foundation Level (2022)
  • Safety Expert Active Medical Devices – TÜV (2017)
• Regulatory Documentation & Support:
  • Contributed to FDA premarket submissions, CE marking technical files, and IECEE CB Scheme reports.
  • Experienced in full software development lifecycle adherence to SOPs and IEC 62304.

• Methodologies: Proficient in Agile (SAFe), V-Model, and Waterfall.
• Software Architecture:
  • Certified Professional for Software Architecture – Foundation Level (2024).
  • Expertise in Software Architecture Design (SAD).
• Documentation:
  • Strong capabilities in Requirements Engineering (SRS), Detailed Design (SDD), Verification Plans & Reports, and Risk Management File contributions.
• Development & Documentation Tools:
  • IDEs: IAR Embedded Workbench, GCC, VS Code, Eclipse.
  • Version Control: Perforce, Git, SVN.
  • Specialized Tools: Sparx Enterprise Architect, Windchill (PTC, RV&S), VectorCAST, Klocwork, JIRA, Confluence, Crucible, TeamCity, NUnit.

“It was great to have Florian on my team. Besides his great technical knowledge, his way of working was a pleasure: collaborative and with a mindset of getting things done. He lived our theme of ‚Doing now what the patient needs next‘.”

YVES DREXLMEIER, Head of FW Development at Roche Diabetes Care GmbH

“It was a pleasure working with Florian for over 10 years on the development, expansion and maintenance of the software for our medical insulin delivery system. As the Integration Test Lead, I saw first-hand how Florian consistently delivered high-quality, robust code that met stringent regulatory requirements. I was particularly impressed by his deep understanding of embedded systems, cybersecurity and Bluetooth Low Energy. His commitment to detail significantly streamlined our integration testing efforts, and he consistently found and fixed bugs quickly, making the testing and validation phases exceptionally smooth. He always provided well-documented software, demonstrating his highly skilled and reliable professionalism. Florian would be a valuable asset to any team in the medical device industry.”

ATILA MEJIA MARTINEZ, Software Test Engineer at Roche Diabetes Care GmbH