Senior Embedded Software Engineer | Medical Device Focus
Aktualisiert am 23.08.2025
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 01.10.2025
Verfügbar zu: 100%
davon vor Ort: 50%
Embedded Software
Bluetooth
IEC 62304
IT-Security
Secure coding
Safety Critical Software
SAFe
Softwarearchitektur
Software-Design
Agile Softwareentwicklung
Medizinische Geräte
Medizinprodukte
German
English
French

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

11 Jahre 1 Monat
2014-09 - 2025-09

Embedded Software Development for Insulin Pumps and CGM Sensors

Senior Embedded Software Engineer
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).

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 Bluetooth IEC 62304 IT-Security Secure coding Safety Critical Software SAFe Softwarearchitektur Software-Design Agile Softwareentwicklung Medizinische Geräte Medizinprodukte

Produkte / Standards / Erfahrungen / Methoden

Personal attributes

  • Strong Results-Orientation
  • High Commitment to Quality Standards
  • Proven Reliability & Dependability
  • Practical Hands-on Mentality
  • Analytical Mindset & Problem-Solving Skills
  • Effective Team Collaboration
  • Thoughtful and Reflective Approach
  • Adaptability


About me

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 for medical devices, ensuring Functional Safety and compliance (IEC 62304, ISO 13485). 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


Microcontrollers

  • ARM Cortex-M (M0, M0+, M4): Extensive development experience across platforms from Nordic Semiconductor, STMicroelectronics (STM32), Microchip and Texas Instruments.
  • Texas Instruments MSP430: Experience with 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, 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, TeamCity, NUnit

Programmiersprachen

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

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

11 Jahre 1 Monat
2014-09 - 2025-09

Embedded Software Development for Insulin Pumps and CGM Sensors

Senior Embedded Software Engineer
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).

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 Bluetooth IEC 62304 IT-Security Secure coding Safety Critical Software SAFe Softwarearchitektur Software-Design Agile Softwareentwicklung Medizinische Geräte Medizinprodukte

Produkte / Standards / Erfahrungen / Methoden

Personal attributes

  • Strong Results-Orientation
  • High Commitment to Quality Standards
  • Proven Reliability & Dependability
  • Practical Hands-on Mentality
  • Analytical Mindset & Problem-Solving Skills
  • Effective Team Collaboration
  • Thoughtful and Reflective Approach
  • Adaptability


About me

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 for medical devices, ensuring Functional Safety and compliance (IEC 62304, ISO 13485). 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


Microcontrollers

  • ARM Cortex-M (M0, M0+, M4): Extensive development experience across platforms from Nordic Semiconductor, STMicroelectronics (STM32), Microchip and Texas Instruments.
  • Texas Instruments MSP430: Experience with 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, 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, TeamCity, NUnit

Programmiersprachen

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

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