28.11.2023 aktualisiert
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Berater IVD (In Vitro Diagnostics)
Peissenberg, Deutschland
Weltweit
Master Elektrotechnik/ InformatikSkills
21 CfrSystems EngineeringAutomatisierungBilanzUnternehmensberatungConfiguration ManagementComplianceGeistiges EigentumProzessentwicklungProduktdesignProgramm-ManagementTechnikfolgenabschätzungRisikomanagementDiagnostische Fähigkeiten
Independent Professional providing services to the Medical Device/ IVD In Vitro Diagnostics Industry in the areas:
since 2/2012 with offices in Nevada (Las Vegas South), Germany (Munich South); Ireland (Greencastle); www.your-ideas.net
Interdisciplinary IVD Product-Development/ System Engineering)
Process Development System Engineering, Training and Implementation
Design Control (21 CFR Part 820, ISO13485) with the scalable processes above.
Management Consulting
Complex decision processes, project status & acceleration, automation, product design, technology assessment, intellectual property, organization, “path to market scenarios”.
- Systems Engineering
- Quality and Regulatory
- Management of international product development
since 2/2012 with offices in Nevada (Las Vegas South), Germany (Munich South); Ireland (Greencastle); www.your-ideas.net
Interdisciplinary IVD Product-Development/ System Engineering)
- Project-/ Program Management
- Requirements- & Usability Engineering
- Product Risk Management incl. perspective on all disciplines
- Configuration Management
- Verification & Validation
- Documentation Management
Process Development System Engineering, Training and Implementation
Design Control (21 CFR Part 820, ISO13485) with the scalable processes above.
Management Consulting
Complex decision processes, project status & acceleration, automation, product design, technology assessment, intellectual property, organization, “path to market scenarios”.
Erfahrung
Berufserfahrungmehr als 10 Jahre
Freelancer seit2012
Sprachen
DeutschMutterspracheEnglischverhandlungssicher
Projekthistorie
Management
- Executed gap analysis on design control “needs”
- Executed/ facilitated design reviews for program management
- Established design control procedures for interdisciplinary product development
- Coaching of R&D teams
- Structured & defined modular design history for instrumentation platform and assays jointly with team and functions
- Compiled & coached provision of overarching design history meta documents
- Compiled & coached provision of requirements, product risks, risk mitigations and traceability