28.07.2026 aktualisiert
100 % verfügbar
Senior Medical Device R&D, Regulatory and Executive Consultant
Weßling, Deutschland
Deutschland +7
Dipl.-Informatik Univ.info: Deutschland, Österreich, Schweiz, Frankreich, Belgien, Dänemark, Niederlande, Schweden
Über mich
A senior development engineer and manager in medical device product development. I provide more than 15 years of experience and deep knowledge in development of firmware, software and electronics, including class 3 medical devices and active implants, and management of medical device projects.
Skills
Azure DevOpsInnovationC (Programmiersprache)Medizinische GeräteMedical CodingC#C++SchaltungsdesignContinuous IntegrationDevice ManagementFmeaTraceabilityFreertosMedizinische SoftwareImplantierbarer Kardioverter-Defibrillator
A senior development engineer and manager in medical device product development, with the goal of developing innovative products to improve the quality of life of patients.
I provide many years of experience in management of medical device projects, as well as deep knowledge in development of firmware, software and electronics, including class 3 medical devices and active implants.
I support the development of medical devices from innovation to marketing and I understand how to convert ideas into practicable product solutions and then validate them for their intended use.
I create long-term shareholder value for my customers by supporting development departments in completing new products with a high level of quality in compliance with the budget.
I combine in-depth analytical skills and a deep understanding of complex systems consisting of mechanics, hardware, firmware and software. A special focus is on the usability, safety and effectiveness of active medical systems including active implants.
Areas of expertise:
+ Development of firmware, software and electronics under ISO 13485, ISO 14971, IEC 60601-1 and IEC 62304
+ Design of connected medical devices, including technical documentation and V&V activities
+ Knowledge of regulatory requirements for CE and FDA approval
+ Building up and management of engineering teams
+ Project Management and Product leadership
+ Communicator between different departments of companies, including suppliers and other stakeholders
Sprachen
DeutschMutterspracheEnglischverhandlungssicherFranzösischGrundkenntnisse
Projekthistorie
Responsible for the development of hardware and firmware for an active medical implant and body worn components in the area of cardiac support.
Activities:
- Project coordination and planning
- Hardware / Electronics development
- Firmware development
- Design documentation, regulatory consulting
- Coordination of suppliers
- Transition of design to production
Activities:
- Project coordination and planning
- Hardware / Electronics development
- Firmware development
- Design documentation, regulatory consulting
- Coordination of suppliers
- Transition of design to production
Software development, documentation, testing
• Development of firmware for ARM using Eclipse
• Development of application test software using C#/.Net
• Definition and implementation of the integration and acceptance tests
• Development of firmware for ARM using Eclipse
• Development of application test software using C#/.Net
• Definition and implementation of the integration and acceptance tests
Responsible for the development of hardware and firmware for an active medical implant and body worn components in the area of fluid overload support.
Activities:
- Project coordination and planning
- Hardware / Electronics development
- Firmware development
- Software development
- Design documentation, regulatory consulting
- Coordination of suppliers
- Transition of design to production
Activities:
- Project coordination and planning
- Hardware / Electronics development
- Firmware development
- Software development
- Design documentation, regulatory consulting
- Coordination of suppliers
- Transition of design to production