Independent Professional In Vitro Diagnostics
Keywords
Skills
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”.
Project history
02/2012
-
02/2022
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
Local Availability
Open to travel worldwide
Deutschland, USA, DACH, Europa; remote & TBD