22.04.2023 aktualisiert
40 % verfügbar
Senior Medical Device R&D, Regulatory and Executive Consultant
Weßling, Deutschland
Weßling +250 km
Dipl.-Informatik Univ.Skills
Software EntwicklungC++C#Projekt ManagementQualitätsmanagementMedizintechnikEntwicklung von MedizinprodukteIEC 62304HardwareentwicklungEmbedded Systems / FirmwareIEC 60601-1Regulatory Affairs
Management:
+ Developing and improving company's engineering strategies
+ Technical Business development
+ Bulding up and management of engineering teams
+ Communication, motivation and conflict resolution
+ Mentoring with hands-on mentality
Project Management
+ Project Management (Agile, Traditional)
+ Project Controlling
+ Overall understanding of high-risk medical devices
Software Engineering :
+ Development of Concepts
+ Architecture Design
+ Implementation / Development
+ Testing
+ Release- , Change- and Configuration Management
+ Medical Device Software Development (IEC 62304)
+ Embedded software development
+ Wireless systems
Hardware Engineering:
+ Medical Device Hardware Development (IEC 60601)
+ Schematics & Layout
+ Testing
Quality Management & Regulatory Affairs:
+ Development of quality management systems
+ Internal auditor
+ Supervise external audits
+ Risk Management
+ Supervise regulatory affairs
+ Developing and improving company's engineering strategies
+ Technical Business development
+ Bulding up and management of engineering teams
+ Communication, motivation and conflict resolution
+ Mentoring with hands-on mentality
Project Management
+ Project Management (Agile, Traditional)
+ Project Controlling
+ Overall understanding of high-risk medical devices
Software Engineering :
+ Development of Concepts
+ Architecture Design
+ Implementation / Development
+ Testing
+ Release- , Change- and Configuration Management
+ Medical Device Software Development (IEC 62304)
+ Embedded software development
+ Wireless systems
Hardware Engineering:
+ Medical Device Hardware Development (IEC 60601)
+ Schematics & Layout
+ Testing
Quality Management & Regulatory Affairs:
+ Development of quality management systems
+ Internal auditor
+ Supervise external audits
+ Risk Management
+ Supervise regulatory affairs
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