Profilbild von Juergen Friedrichs Berater IVD (In Vitro Diagnostics) aus Peissenberg

Juergen Friedrichs

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Letztes Update: 28.11.2023

Berater IVD (In Vitro Diagnostics)

Abschluss: Master Elektrotechnik/ Informatik
Stunden-/Tagessatz: anzeigen
Sprachkenntnisse: deutsch (Muttersprache) | englisch (verhandlungssicher)

Dateianlagen

TrackRecordJFriedrichsNovember2023_271123.pdf

Skills

Independent Professional providing services to the Medical Device/ IVD In Vitro Diagnostics Industry in the areas:
 
  • 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”.

 

Projekthistorie

02/2012 - 02/2022
Beratung/ Consulting Beispiele
(Pharma und Medizintechnik, 1000-5000 Mitarbeiter)

Management
  • Executed gap analysis on design control “needs”
  • Executed/ facilitated design reviews for program management
Quality and Regulatory
  • Established design control procedures for interdisciplinary product development
  • Coaching of R&D teams
R&D
  • 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

Reisebereitschaft

Weltweit verfügbar
Deutschland, USA, DACH, Europa; remote & teilweise vor Ort
Profilbild von Juergen Friedrichs Berater IVD (In Vitro Diagnostics) aus Peissenberg Berater IVD (In Vitro Diagnostics)
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