Project management, purchasing of equipment, commissioning, qualification & validation
Working in the field to develop medical devices and the production equipment needed
Know-how ranges from the design of hand-held tools up to the development of complex products in the fields of medical and measurement technologies
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Our content and services may vary by location.
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Overview
- Availability
- Asap, 5 days/week, on-site & remote
- Qualification
- Mechanical Engineer; State-Certified Engineer
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Quality Management Representive, Design (CAD / 3D), Manufacturing Processes (GMP / GXP / GAMP), Medical Device Registration In Switzerland and the EU, Verification / Validation, Qualification (IQ; OQ; PQ), Product Specification (URS / DRS / HRS / SRS), Process Optimization, Risk Analysis (FMEA), MDR / IVDR, ISO 13485, Medtech
Key-Facts
Extract from previous activities
Medical Device Company, Switzerland
Interim Head of Quality Management
Successful implementation of a quality management system and registration of 5 IVDs according to IVDD/IVDR in Switzerland and the EU
Responsibility for the completeness of the development and approval documentation and CE self-declaration
Medical Device Company, Germany
Interim Manager
Realisation of a preliminary project for the application of new technologies for 3T hypothermal units
Cooling and Heating processes
Medical Device Company, Switzerland
Consultant / Senior Validation Engineer
Verification/validation of various test methods (static and dynamic tests)
Qualification of the test equipment used by MST (Material Science and Testing Laboratory)
Design- and Implementation-Support of Certification, Validation, GMP-Commissioning Strategy for technical infrastructure (clean rooms)
Medical Device Company, Germany
Consultant / Project Manager
Responsible for the company certification in accordance with ISO 13485
Certification of 3 OEM products
Medical Device Company, Germany
Interim Manager R&D
Execution of a product analysis, a technical and economic evaluation of a Mini-HLM (Heart-Lung Machine)
Medical Device Company, Germany
Interim Project Manager
Responsible for the development of a new technology of a modular heart support system
Development / production of an extracorporeal cardiac support system
Product development and process optimisation from prototype to the serial product
Developing and organization of the production, process optimization, GAMP