IVD and Laboratory Instrumentation Development Proven Leader of International Teams Expert in Requirements Engineering & Verification QMS Auditor
Aktualisiert am 01.08.2024
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 01.08.2024
Verfügbar zu: 100%
davon vor Ort: 80%
Project Management
Medizinprodukte
Qualitymanagement
Changemanagement
Agile Coach
Systemanalyse
Diagnostik
Regualtorische Beratung
Förderanträge

Einsatzorte

Einsatzorte

Freising (+300km)
Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

4 Jahre 7 Monate
2020-03 - heute

development of complex molecualar diagnostics analyzer

Project- / Program manager
Project- / Program manager

Responsibility for all processes from marketing to design input to design output and transfer to production, including design reviews as well as support to risk management and usability engineering.

  • Overall responsibility for the development of complex molecualar diagnostics analyzer.
  • Leading interdisciplinary teams of 10-15 engineers.
  • Coordination of Electronics-, Software-, Optics- and Mechanical Engineers.
  • Responisbility for budget, timeline and customer communication.
  • Close collaboration with microfluidic cartridge developer

LRE Medical
4 Monate
2019-11 - 2020-02

Auditing of Quality Management Systems

Auditor & Product Specialist
Auditor & Product Specialist
  • Auditing of Quality Management Systems of IVD companies
  • Conformity Assessment of Technical Documentation of IVD products
TÜV Süd Product Service GmbH
1 Jahr 9 Monate
2018-03 - 2019-11

Development of medical devices

Self-employed Technology Consultant
Self-employed Technology Consultant
  • Lifecycle Management, Change Coordination, Requirements Engineering, Design Verification
  • GAP analysis regarding compliance to technical standards
  • Remediation activities
  • Submission preparation / DHF check
  • Writing proposal for public funding
on request

Aus- und Weiterbildung

Aus- und Weiterbildung

2022 - today

Systems and Project Management (MBA)

Hochschule Landshut


2007 - 2011

Applied Bio-Physics

PhD

LMU, Munich, AG Tinnefeld


2002 - 2007

Molecular Biotechnology

Diploma

University of Bielefeld


Cerification

  • Project Manager
  • In-vitro-Diagnostics Manager (regulatory training regarding IVDR)
  • QMF
  • QMS/IVD Auditor

Kompetenzen

Kompetenzen

Top-Skills

Project Management Medizinprodukte Qualitymanagement Changemanagement Agile Coach Systemanalyse Diagnostik Regualtorische Beratung Förderanträge

Produkte / Standards / Erfahrungen / Methoden

Profile

  • Open, honest and direct communication.
  • Passionate about leadership of international teams within matrix organizations.
  • Instrument development expert with 12 years experience in development of complex instruments for in-Vitro diagnostic and laboratory applications.
  • Expert in FDA and CE compliant processes for Requirements Engineering, Verification, Validation, Usability and Risk Management.
  • Broad scientific and engineering background with focus on optical detection systems, laser applications and microscopy.


Knowledge

  • Project Management
  • Leadership and social skills
  • QMS ISO 13485 und 21 CFR Part 820
  • Auditing techniques & Internal Audits
  • Molecular Biotechnology
  • Laser based imaging and analysis technologies
  • Requirements Engineering, Design Verification
  • Regulatory Affairs: CE, MDR, IVDR 2017/746, RED
  • Risk Management ISO 14971
  • Needle based injection systems ISO 11608
  • Usability Engineering EN 62366
  • IEC 61010 family
  • IEC 60601 family
  • Entrepreneurship


Work Experience

Place of Work: Europe

Customer: R&D consortium


Tasks:

  • EU R&D project


Place of Work: USA

Customer: Fortune 500


Tasks:

  • Multiplex PCR for PoC


Place of Work: International

Customer: Start-up


Tasks:

  • Multiplex PCR instrument


Place of Work: International

Customer: Fortune 500


Tasks:

  • Lifecycle management


Place of Work: Germany

Customer: Start-up


Tasks:

  • Extension of product portfolio


Place of Work: Germany

Customer: SME


Tasks:

  • Instrument platform


Place of Work: Germany

Customer: Start-up


Tasks:

  • Charging station


Place of Work: Europe

Customer: R&D consortium


Tasks:

  • EU R&D project


Place of Work: Canada

Customer: SME


Tasks:

  • Fluorescence Reader


Netherlands

Fortune 500


Tasks:

  • Cooled blood analyzer


Place of Work: Germany

Customer: Fortune 500


Tasks:

  • Thermoreactor


Place of Work: USA

Customer: Start-up


Tasks:

  • Fluorescence Reader


Place of Work: Switzerland

Customer: SME


Tasks:

  • Optical tweezers
  • Laser Microdissection


Place of Work: Switzerland

Customer: R&D consortium


Tasks:

  • EU R&D project

Einsatzorte

Einsatzorte

Freising (+300km)
Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

4 Jahre 7 Monate
2020-03 - heute

development of complex molecualar diagnostics analyzer

Project- / Program manager
Project- / Program manager

Responsibility for all processes from marketing to design input to design output and transfer to production, including design reviews as well as support to risk management and usability engineering.

  • Overall responsibility for the development of complex molecualar diagnostics analyzer.
  • Leading interdisciplinary teams of 10-15 engineers.
  • Coordination of Electronics-, Software-, Optics- and Mechanical Engineers.
  • Responisbility for budget, timeline and customer communication.
  • Close collaboration with microfluidic cartridge developer

LRE Medical
4 Monate
2019-11 - 2020-02

Auditing of Quality Management Systems

Auditor & Product Specialist
Auditor & Product Specialist
  • Auditing of Quality Management Systems of IVD companies
  • Conformity Assessment of Technical Documentation of IVD products
TÜV Süd Product Service GmbH
1 Jahr 9 Monate
2018-03 - 2019-11

Development of medical devices

Self-employed Technology Consultant
Self-employed Technology Consultant
  • Lifecycle Management, Change Coordination, Requirements Engineering, Design Verification
  • GAP analysis regarding compliance to technical standards
  • Remediation activities
  • Submission preparation / DHF check
  • Writing proposal for public funding
on request

Aus- und Weiterbildung

Aus- und Weiterbildung

2022 - today

Systems and Project Management (MBA)

Hochschule Landshut


2007 - 2011

Applied Bio-Physics

PhD

LMU, Munich, AG Tinnefeld


2002 - 2007

Molecular Biotechnology

Diploma

University of Bielefeld


Cerification

  • Project Manager
  • In-vitro-Diagnostics Manager (regulatory training regarding IVDR)
  • QMF
  • QMS/IVD Auditor

Kompetenzen

Kompetenzen

Top-Skills

Project Management Medizinprodukte Qualitymanagement Changemanagement Agile Coach Systemanalyse Diagnostik Regualtorische Beratung Förderanträge

Produkte / Standards / Erfahrungen / Methoden

Profile

  • Open, honest and direct communication.
  • Passionate about leadership of international teams within matrix organizations.
  • Instrument development expert with 12 years experience in development of complex instruments for in-Vitro diagnostic and laboratory applications.
  • Expert in FDA and CE compliant processes for Requirements Engineering, Verification, Validation, Usability and Risk Management.
  • Broad scientific and engineering background with focus on optical detection systems, laser applications and microscopy.


Knowledge

  • Project Management
  • Leadership and social skills
  • QMS ISO 13485 und 21 CFR Part 820
  • Auditing techniques & Internal Audits
  • Molecular Biotechnology
  • Laser based imaging and analysis technologies
  • Requirements Engineering, Design Verification
  • Regulatory Affairs: CE, MDR, IVDR 2017/746, RED
  • Risk Management ISO 14971
  • Needle based injection systems ISO 11608
  • Usability Engineering EN 62366
  • IEC 61010 family
  • IEC 60601 family
  • Entrepreneurship


Work Experience

Place of Work: Europe

Customer: R&D consortium


Tasks:

  • EU R&D project


Place of Work: USA

Customer: Fortune 500


Tasks:

  • Multiplex PCR for PoC


Place of Work: International

Customer: Start-up


Tasks:

  • Multiplex PCR instrument


Place of Work: International

Customer: Fortune 500


Tasks:

  • Lifecycle management


Place of Work: Germany

Customer: Start-up


Tasks:

  • Extension of product portfolio


Place of Work: Germany

Customer: SME


Tasks:

  • Instrument platform


Place of Work: Germany

Customer: Start-up


Tasks:

  • Charging station


Place of Work: Europe

Customer: R&D consortium


Tasks:

  • EU R&D project


Place of Work: Canada

Customer: SME


Tasks:

  • Fluorescence Reader


Netherlands

Fortune 500


Tasks:

  • Cooled blood analyzer


Place of Work: Germany

Customer: Fortune 500


Tasks:

  • Thermoreactor


Place of Work: USA

Customer: Start-up


Tasks:

  • Fluorescence Reader


Place of Work: Switzerland

Customer: SME


Tasks:

  • Optical tweezers
  • Laser Microdissection


Place of Work: Switzerland

Customer: R&D consortium


Tasks:

  • EU R&D project

Vertrauen Sie auf Randstad

Im Bereich Freelancing
Im Bereich Arbeitnehmerüberlassung / Personalvermittlung

Fragen?

Rufen Sie uns an +49 89 500316-300 oder schreiben Sie uns:

Das Freelancer-Portal

Direktester geht's nicht! Ganz einfach Freelancer finden und direkt Kontakt aufnehmen.