Product owner for automated laboratory equipment. Manage Display component team and Remover module team with each 3 engineers. Scrum meetings and planning with the teams. Interface with management. Propose solutions for technical problems. Manage releases and interface with verification teams and on market teams. Manage Problems, enhancements and CAPA?s. in Germany and in the United States.
Development and integration of Motion-Controller-Software for autonomous driving.
Technical environment:
Infusion pump:
Implementation of new features and correction of bugs.
Software System validation of new release production code. Including test documentation, creation of new test cases, unit test setup, electronic measurements, update of requirement documents and detailed design documents. Customer complaint investigation.
inhalator monitor: Development of embedded software with Bluetooth connection.
COVID testing software running in browser for use with DNA sequencer. Code review and code improvements. Creation of SW design documentation (requirements, architecture, detailed design, lifecycle document etc.)
Prove Of Concepts for pharmaceutical equipment on OPCUA Location Discovery Server and a connector process for connecting to a Rockwell PLC.
Robot Arm (STM32)
? Migration of SW projects from IAR to TrueSTUDIO Atollic
? Production tool development in Python
ESP32 to Thingsboard connection (IoT) prove of concept:
? Setup of secure connection (TLS1.2) MQTT with Thingsboard
Human milk pump (ESP32):
? Design documentation: project plan, requirements, architecture, detailed design, risk management.
? Implementation of pressure sensor (BMP280) and LED drivers and Code cleanup of existing code.
1) I have managed the complete software life-cycle for the product the product (Medical device, Class B software, Good Design® Award 2018).
· I have created and managed the technical documentation to reply to the standard IEC 62 304. This included the Software life-cycle plan, risk management, Software requirements, Architecture, Detailed design. Participated in FDA 510(k) submissions.
· I was responsible for the firmware implementation. A part I have outsourced to a third party, and a major part I implemented with my team member. This resulted in the first production code that was successfully launched in march 2017. Start production was 5000 devices per year. Since then I have released 4 maintenance releases for performance improvement and functional enhancements.
· Outsourcing of development activities for the wireless pedal software, and follow up (Subcontractor selection, device specification, support of consulting company, test, integration of pedal with the product). I released one wireless pedal maintenance release after the first production release. I have also ported the code to another long range Bluetooth module.
· Unit testing (software validation) of medical software with LDRA Tbrun.
· Software planning with Agile methodologies, definition of work packages and alignment of the work packages with the hardware planning.
· Organized and executed the Software Risk analysis.
· Requirements tracking with LDRA TBreq in the documentation from design input to unit test documentation
· During the above tasks I worked together in a multi disciplined team to assure the correct working of the mechanics, electronics, hydraulics and pneumatic and powder. As part of my tasks I have trained the after-sales service team and the production team. And I have been working closely with the quality team to have the software validated and verified.
· Definition and implementation of the service tool that helps the after-sales team and the production team to setup the device configuration and to analyse technical issues. Log data is downloaded with this tool from the device by after-sales for data analyses and statistics on the device usage. This data is stored in a SQL database.
2) Development of the software for the RFID module for a new Medical physio-therapeutic device for prove of concept for the given hardware.
3) Ultrasound module prove of concept for a new algorithm for a dental scaler. Selection of processor, electronic board test, software architecture and implementation of a part of the software.01/2009 ? 01/2012:
Institution: Audencia Nantes School of Management (FR), Université Paul Cézanne (FR), Maastricht Business School (NL), HHL ? Leipzig (D), EADA (S), Kozminski Academy of Entrepreneurship and Management (PL)
Degree: Executive Master Of Business Administration (EMBA)
thesis: Gladly on request
1988-1992:
Institution: Hogeschool Haarlem, the Netherlands
Education: HTS Electronics
Degree: Engineering degree
Training:
09/2018:
Introduction to Artificial Intelligence (AI), EDX online training by Microsoft using Python and Azure
2018:
2017:
Software Design for Medical Devices, Congress
2016:
2015:
Training IEC-60 601 TÜV Rheinland
2007:
LDRA Training for the software standards compliance, testing, and verification tool LDRA. Training given by LDRA. 2013 (3 days) Managing Projects ESI International
Embedded Systems & Software Engineer
Profile:
26 years of experience in Embedded Software and Hardware engineering
Software:
Norms:
Medical Device Regulations, IEC62304, IEC60601, FDA guidelines, CMMI, document control(Fagan Inspection).
Design:
UML, Object oriented design(Coad & Yourdon), Real time development methodes (Ward & Mellor).
Medical
Communication
Digital video
Consumer electronics
Defense
Dutch national police.
Entfernung nach Freiburg im Breisgau: 45 Minuten
Entfernung nach Basel: 20 Minuten
Product owner for automated laboratory equipment. Manage Display component team and Remover module team with each 3 engineers. Scrum meetings and planning with the teams. Interface with management. Propose solutions for technical problems. Manage releases and interface with verification teams and on market teams. Manage Problems, enhancements and CAPA?s. in Germany and in the United States.
Development and integration of Motion-Controller-Software for autonomous driving.
Technical environment:
Infusion pump:
Implementation of new features and correction of bugs.
Software System validation of new release production code. Including test documentation, creation of new test cases, unit test setup, electronic measurements, update of requirement documents and detailed design documents. Customer complaint investigation.
inhalator monitor: Development of embedded software with Bluetooth connection.
COVID testing software running in browser for use with DNA sequencer. Code review and code improvements. Creation of SW design documentation (requirements, architecture, detailed design, lifecycle document etc.)
Prove Of Concepts for pharmaceutical equipment on OPCUA Location Discovery Server and a connector process for connecting to a Rockwell PLC.
Robot Arm (STM32)
? Migration of SW projects from IAR to TrueSTUDIO Atollic
? Production tool development in Python
ESP32 to Thingsboard connection (IoT) prove of concept:
? Setup of secure connection (TLS1.2) MQTT with Thingsboard
Human milk pump (ESP32):
? Design documentation: project plan, requirements, architecture, detailed design, risk management.
? Implementation of pressure sensor (BMP280) and LED drivers and Code cleanup of existing code.
1) I have managed the complete software life-cycle for the product the product (Medical device, Class B software, Good Design® Award 2018).
· I have created and managed the technical documentation to reply to the standard IEC 62 304. This included the Software life-cycle plan, risk management, Software requirements, Architecture, Detailed design. Participated in FDA 510(k) submissions.
· I was responsible for the firmware implementation. A part I have outsourced to a third party, and a major part I implemented with my team member. This resulted in the first production code that was successfully launched in march 2017. Start production was 5000 devices per year. Since then I have released 4 maintenance releases for performance improvement and functional enhancements.
· Outsourcing of development activities for the wireless pedal software, and follow up (Subcontractor selection, device specification, support of consulting company, test, integration of pedal with the product). I released one wireless pedal maintenance release after the first production release. I have also ported the code to another long range Bluetooth module.
· Unit testing (software validation) of medical software with LDRA Tbrun.
· Software planning with Agile methodologies, definition of work packages and alignment of the work packages with the hardware planning.
· Organized and executed the Software Risk analysis.
· Requirements tracking with LDRA TBreq in the documentation from design input to unit test documentation
· During the above tasks I worked together in a multi disciplined team to assure the correct working of the mechanics, electronics, hydraulics and pneumatic and powder. As part of my tasks I have trained the after-sales service team and the production team. And I have been working closely with the quality team to have the software validated and verified.
· Definition and implementation of the service tool that helps the after-sales team and the production team to setup the device configuration and to analyse technical issues. Log data is downloaded with this tool from the device by after-sales for data analyses and statistics on the device usage. This data is stored in a SQL database.
2) Development of the software for the RFID module for a new Medical physio-therapeutic device for prove of concept for the given hardware.
3) Ultrasound module prove of concept for a new algorithm for a dental scaler. Selection of processor, electronic board test, software architecture and implementation of a part of the software.01/2009 ? 01/2012:
Institution: Audencia Nantes School of Management (FR), Université Paul Cézanne (FR), Maastricht Business School (NL), HHL ? Leipzig (D), EADA (S), Kozminski Academy of Entrepreneurship and Management (PL)
Degree: Executive Master Of Business Administration (EMBA)
thesis: Gladly on request
1988-1992:
Institution: Hogeschool Haarlem, the Netherlands
Education: HTS Electronics
Degree: Engineering degree
Training:
09/2018:
Introduction to Artificial Intelligence (AI), EDX online training by Microsoft using Python and Azure
2018:
2017:
Software Design for Medical Devices, Congress
2016:
2015:
Training IEC-60 601 TÜV Rheinland
2007:
LDRA Training for the software standards compliance, testing, and verification tool LDRA. Training given by LDRA. 2013 (3 days) Managing Projects ESI International
Embedded Systems & Software Engineer
Profile:
26 years of experience in Embedded Software and Hardware engineering
Software:
Norms:
Medical Device Regulations, IEC62304, IEC60601, FDA guidelines, CMMI, document control(Fagan Inspection).
Design:
UML, Object oriented design(Coad & Yourdon), Real time development methodes (Ward & Mellor).
Medical
Communication
Digital video
Consumer electronics
Defense
Dutch national police.
Direktester geht's nicht! Ganz einfach Freelancer finden und direkt Kontakt aufnehmen.
Für Schweizer Kunden kann ich ein Projekt völlig legal durchführen und die Tage, an denen ich in der Schweiz arbeite, bei der zuständigen Behörde des Kantons melden.
Entfernung nach Freiburg im Breisgau: 45 Minuten
Entfernung nach Basel: 20 Minuten