Senior Embedded Software Engineer | Medical Device Focus
Aktualisiert am 21.03.2026
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 23.03.2026
Verfügbar zu: 100%
davon vor Ort: 50%
Embedded Software
IEC 62304
Cyber Security (Embedded)
IT-Security
Secure coding
Safety Critical Software
Softwarearchitektur
Agile Softwareentwicklung
Medizinprodukte
Zephyr RTOS
Embedded C
C++
ARM Cortex
STM32
Bluetooth
Funktionale Sicherheit
VectorCAST
Verschlüsselung
DIN 13485
Low Power Device
ISO 14971
CI/CD
Internet of Things
German
English
French

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

3 Monate
2025-10 - 2025-12

Feasibility Study - Migration to Zephyr RTOS

Embedded Systems Architect Zephyr RTOS STM32 C ...
Embedded Systems Architect
  • Architecture: Designed the migration path and defined software interfaces/adaptation layers to maintain compatibility with legacy test frameworks.
  • Implementation: Developed a C/C++ Proof of Concept (PoC) to verify feasibility, real-time behavior, and memory usage on the target hardware.
  • Consulting: Provided a comprehensive technical report and detailed effort estimation to clarify technical hurdles before full-scale development.
Zephyr RTOS STM32 C ARM Cortex CMake System Architecture
11 Jahre 1 Monat
2014-09 - 2025-09

Embedded Software Development for Insulin Pumps and CGM Sensors

Senior Embedded Software Engineer Embedded C Embedded C++ Python ...
Senior Embedded Software Engineer
Medical Device Software Development (IEC 62304)
Executed the full software development lifecycle for medical device software, from requirements analysis through implementation and unit verification, adhering to internal Standard Operating Procedures (SOPs) and the IEC 62304 standard.


Embedded System Integration & Vendor Management

Implemented a serial inter-processor communication (IPC) interface to integrate third party OTS/SOUP software with the nRF51 MCU; also managed supplier communications regarding changes and bug fixes, and provided active support during integration testing against the peer device.


System Evolution & Modernization

Supported system evolution through key hardware and software modernization efforts, including:
  • Developing custom firmware for the nRF52 platform (based on Nordic SDK) as a replacement for prior OTS software, coinciding with the nRF51 hardware migration.
  • Supporting the selection process and porting software for the transition from an end-of-life (EOL) 16-bit TI MSP430 MCU to a modern STM32U0 MCU.
  • Evaluating and integrating an SPI-interfaced micropower differential angle sensor to enhance motor control precision.


Security Implementation & Cybersecurity Assurance

Integrated the Bluetooth Authorization Control Service (ACS) using X.509 certificates within an Identity and Access Management (IAM) framework, applying AES-based encryption on the application layer, to ensure Secure Plug & Play Interoperability for Automated Insulin Delivery (AID) devices. Provided comprehensive support during Cybersecurity Assessments (including Penetration Testing) conducted by the Fraunhofer Institute for Secure Information Technology (SIT), which involved providing test devices/documentation/information, addressing assessment team questions, and participating in the discussion/remediation of findings, contributing to the successful attestation


Regulatory Documentation & Support

Contributed technical documentation and support for regulatory submissions and certifications, including FDA premarket submissions, CE marking technical files, and IECEE CB Scheme reports.


Bluetooth Standardization & Qualification

Actively participated in the Bluetooth Low Energy standardization of Insulin Delivery Service (IDS) and Authorization Control Service (ACS) by engaging in technical discussions, developing prototypes and actively executing interoperability tests during IOP events. Played a key role in the Bluetooth Low Energy (BLE) qualification of multiple products, with responsibilities including performing tests using the Profile Tuning Suite (PTS), documenting rationales for necessary waivers/deviations, and serving as the technical liaison with the Qualification Consultant (BQE).

Embedded C Embedded C++ Python STM32 ARM Cortex Nordic Semiconductor TI MSP430 IEC 62304 Medizinprodukte Funktionale Sicherheit IT-Security Bluetooth Verschlüsselung Low Power VectorCAST IAR Embedded Workbench Git GitLab Perforce Subversion Requirements Engineering
Mannheim

Aus- und Weiterbildung

Aus- und Weiterbildung

4 Jahre 7 Monate
2005-10 - 2010-04

Studies in Computer Engineering

Dipl.-Ing. (FH), TH Mittelhessen
Dipl.-Ing. (FH)
TH Mittelhessen
 Low level software development, Embedded Systems, Electronics  

Kompetenzen

Kompetenzen

Top-Skills

Embedded Software IEC 62304 Cyber Security (Embedded) IT-Security Secure coding Safety Critical Software Softwarearchitektur Agile Softwareentwicklung Medizinprodukte Zephyr RTOS Embedded C C++ ARM Cortex STM32 Bluetooth Funktionale Sicherheit VectorCAST Verschlüsselung DIN 13485 Low Power Device ISO 14971 CI/CD Internet of Things

Schwerpunkte

Embedded Software Engineering
Experte

Senior Embedded Software Engineer (>15 Jahre) | MedTech & Safety-Critical | IEC 62304 | Cybersecurity

Ich bin spezialisiert auf die Entwicklung sicherheitskritischer Embedded Software für die Medizintechnik. Mein Fokus liegt auf Systemen, die hohe regulatorische Hürden (IEC 62304, FDA) meistern müssen, ohne dabei technische Kompromisse bei Performance oder Sicherheit einzugehen.
Meine Schwerpunkte:

  • Software-Architektur & Entwicklung: C/C++ (MISRA), ARM Cortex-M, Zephyr RTOS.

  • Functional Safety: Langjährige Erfahrung mit Class C Software nach IEC 62304 und Risikomanagement (ISO 14971).

  • Cybersecurity: Implementierung von Security-Features (AES, X.509) im Embedded-Umfeld (MDR-konform).

  • Connectivity: Tiefes Expertenwissen in Bluetooth Low Energy (BLE), inkl. Custom Profiles und Interoperabilität.

  • Modernisierung: Migration von Legacy-Code (z. B. MSP430) auf moderne Architekturen (STM32, nRF52).

Programmiersprachen

C (C99/C11/C18, MISRA C:2023)
C++
Python

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

3 Monate
2025-10 - 2025-12

Feasibility Study - Migration to Zephyr RTOS

Embedded Systems Architect Zephyr RTOS STM32 C ...
Embedded Systems Architect
  • Architecture: Designed the migration path and defined software interfaces/adaptation layers to maintain compatibility with legacy test frameworks.
  • Implementation: Developed a C/C++ Proof of Concept (PoC) to verify feasibility, real-time behavior, and memory usage on the target hardware.
  • Consulting: Provided a comprehensive technical report and detailed effort estimation to clarify technical hurdles before full-scale development.
Zephyr RTOS STM32 C ARM Cortex CMake System Architecture
11 Jahre 1 Monat
2014-09 - 2025-09

Embedded Software Development for Insulin Pumps and CGM Sensors

Senior Embedded Software Engineer Embedded C Embedded C++ Python ...
Senior Embedded Software Engineer
Medical Device Software Development (IEC 62304)
Executed the full software development lifecycle for medical device software, from requirements analysis through implementation and unit verification, adhering to internal Standard Operating Procedures (SOPs) and the IEC 62304 standard.


Embedded System Integration & Vendor Management

Implemented a serial inter-processor communication (IPC) interface to integrate third party OTS/SOUP software with the nRF51 MCU; also managed supplier communications regarding changes and bug fixes, and provided active support during integration testing against the peer device.


System Evolution & Modernization

Supported system evolution through key hardware and software modernization efforts, including:
  • Developing custom firmware for the nRF52 platform (based on Nordic SDK) as a replacement for prior OTS software, coinciding with the nRF51 hardware migration.
  • Supporting the selection process and porting software for the transition from an end-of-life (EOL) 16-bit TI MSP430 MCU to a modern STM32U0 MCU.
  • Evaluating and integrating an SPI-interfaced micropower differential angle sensor to enhance motor control precision.


Security Implementation & Cybersecurity Assurance

Integrated the Bluetooth Authorization Control Service (ACS) using X.509 certificates within an Identity and Access Management (IAM) framework, applying AES-based encryption on the application layer, to ensure Secure Plug & Play Interoperability for Automated Insulin Delivery (AID) devices. Provided comprehensive support during Cybersecurity Assessments (including Penetration Testing) conducted by the Fraunhofer Institute for Secure Information Technology (SIT), which involved providing test devices/documentation/information, addressing assessment team questions, and participating in the discussion/remediation of findings, contributing to the successful attestation


Regulatory Documentation & Support

Contributed technical documentation and support for regulatory submissions and certifications, including FDA premarket submissions, CE marking technical files, and IECEE CB Scheme reports.


Bluetooth Standardization & Qualification

Actively participated in the Bluetooth Low Energy standardization of Insulin Delivery Service (IDS) and Authorization Control Service (ACS) by engaging in technical discussions, developing prototypes and actively executing interoperability tests during IOP events. Played a key role in the Bluetooth Low Energy (BLE) qualification of multiple products, with responsibilities including performing tests using the Profile Tuning Suite (PTS), documenting rationales for necessary waivers/deviations, and serving as the technical liaison with the Qualification Consultant (BQE).

Embedded C Embedded C++ Python STM32 ARM Cortex Nordic Semiconductor TI MSP430 IEC 62304 Medizinprodukte Funktionale Sicherheit IT-Security Bluetooth Verschlüsselung Low Power VectorCAST IAR Embedded Workbench Git GitLab Perforce Subversion Requirements Engineering
Mannheim

Aus- und Weiterbildung

Aus- und Weiterbildung

4 Jahre 7 Monate
2005-10 - 2010-04

Studies in Computer Engineering

Dipl.-Ing. (FH), TH Mittelhessen
Dipl.-Ing. (FH)
TH Mittelhessen
 Low level software development, Embedded Systems, Electronics  

Kompetenzen

Kompetenzen

Top-Skills

Embedded Software IEC 62304 Cyber Security (Embedded) IT-Security Secure coding Safety Critical Software Softwarearchitektur Agile Softwareentwicklung Medizinprodukte Zephyr RTOS Embedded C C++ ARM Cortex STM32 Bluetooth Funktionale Sicherheit VectorCAST Verschlüsselung DIN 13485 Low Power Device ISO 14971 CI/CD Internet of Things

Schwerpunkte

Embedded Software Engineering
Experte

Senior Embedded Software Engineer (>15 Jahre) | MedTech & Safety-Critical | IEC 62304 | Cybersecurity

Ich bin spezialisiert auf die Entwicklung sicherheitskritischer Embedded Software für die Medizintechnik. Mein Fokus liegt auf Systemen, die hohe regulatorische Hürden (IEC 62304, FDA) meistern müssen, ohne dabei technische Kompromisse bei Performance oder Sicherheit einzugehen.
Meine Schwerpunkte:

  • Software-Architektur & Entwicklung: C/C++ (MISRA), ARM Cortex-M, Zephyr RTOS.

  • Functional Safety: Langjährige Erfahrung mit Class C Software nach IEC 62304 und Risikomanagement (ISO 14971).

  • Cybersecurity: Implementierung von Security-Features (AES, X.509) im Embedded-Umfeld (MDR-konform).

  • Connectivity: Tiefes Expertenwissen in Bluetooth Low Energy (BLE), inkl. Custom Profiles und Interoperabilität.

  • Modernisierung: Migration von Legacy-Code (z. B. MSP430) auf moderne Architekturen (STM32, nRF52).

Programmiersprachen

C (C99/C11/C18, MISRA C:2023)
C++
Python

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