Schlagwörter
Skills
- Projektleitung technische Entwicklung in den Bereichen Medizintechnik, IT, Life Sciences einschließlich Pharma
- Business Analyse - Analyse von Prozessen, formale Notation (BPMN), Konzeption, Design
- Requirements Engineering
- (Multi-)Projektmanagement
- Technische Leitung im regulierten Umfeld (GMP, MDR)
Projekthistorie
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Project lead and management for the development of a software platform for the exchange of health data in accordance with privacy laws.Responsible for all aspects of a project from inception to delivery
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Manage multiple stakeholders
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Develop and validate requirements with different parties involved
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Develop fine specification with team
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Deliver platform within projected time and budget
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Project lead: develop a platform for process design for life sciences.
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Requirements engineering for multiple projects in life sciences and health.
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Develop concepts for automation projects in life sciences.
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Requirements engineering lead for a cross-organization consortium project.
Development of a new technology for synthetic biology.
Launch a startup company, build team, develop business model, technical development, market research, aquisition, negotiation with customers and suppliers.
- Development of a software platform for biolaboratories.
- Carry out market research to determine requirements and user needs.
- Elicit requirements
- Develop fine specification, application architecture
- Develop projects plans with timeline, budget.
- Technical lead for software development.
- Project lead: Introduction of a quality management system for ISO 13485.
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Project lead: Development of a medical device - in-vitro diagnostic platform for multiple blood tests.
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Project lead for development of a complex analytical instruments for highly parallel cytotoxicity testing.
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Responsible for risk management, develop risk plans, implement processes and supervise.
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Development and regulatory approval of medical devices in accordance with 93/42/EWG und IEC 60601-1.
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Project lead for a research project: identify biomarkers for rare diseases.