Design Control Engineering
Senior Consultant Regulatory Affairs
Available for: Tasks
- Project management, design control.
- Medical device engineering, extensive HW/SW and semiconductor knowledge.
- Product conformity assessment, product classification, GAP analysis.
- Risk assessment analysis.
- Software engineering: C, Assembler.
- Electronics engineering, embedded systems, digital.
- Signal processing. Reverse engineering documentation.
- Development of high-risk medical systems, dual channel HW/SW safety systems for defibrillators and cardiac pace-makers, algorithms for ventricular fibrillation detection (AED’s).
- Product approvals for medical devices, FDA (510k), TÜV.
- Medical device development and project management within the area of cardiac emergency equipment, intensive care, Holter ECG and patient quality assurance systems verification and validation of high-risk cardiac medical devices.
Extensive knowledge in:
- ISO 62304 software
- ISO 14971 risk management
- ISO 62366 usability
- IEC 60601
- IEC 61010
- IEC 61326
- MDR 2017/745
- IVDR 2017/746
- General specifications
Has a pragmatic and constructive approach and believes that results are best achieved in a straight forward open minded dialogue between the parties.
He has experience in overviewing the entire structure of a company and can integrate himself quickly into new environments.
Spends his spare time out in the nature enjoying wildlife with his black Labrador, always at his side.