freiberufler Regulated industries expert ― Medical Devices, Life Sciences, Aerospace/Defense auf

Regulated industries expert ― Medical Devices, Life Sciences, Aerospace/Defense

zuletzt online vor wenigen Tagen
  • 88‐111€/Stunde
  • Deutschland
  • auf Anfrage
  • en  |  de
  • 06.02.2021


Consulting roles in regulated industries ― Medical Devices, Life Sciences, Aerospace/Defense: Program-/Project Management, QA/RA, GRC, Innovation Management, Digital Transformation, IoT, Industry 4.0, Cloud, Organizational Excellence

Ich biete

  • APQP (Advanced Product Quality Planning)
  • Compliance management
  • Embedded Systems
  • FMEA (Failure Mode and Effects Analysis)
  • FMECA (Failure Mode and Effects and Criticality Analysis)
  • Innovationsmanagement
  • Kanban (Softwareentwicklung)
  • Luft- und Raumfahrttechnik (allg.)
  • Machbarkeitsanalyse
  • Medizintechnik / Labortechnik
  • Partner relationship management (PRM)
  • Programm Management
  • Projektmanagement
  • Prozess- / Workflow
  • Prozessmanagement
  • Prozessoptimierung
  • Qualitätsmanagement (allg.)
  • Requirement Analyse
  • Risikomanagement
  • System Architektur
  • System Design

Projekt‐ & Berufserfahrung

Consultant in Digital Transformation / IoT / Industry 4.0 / Factory Automation
Kundenname anonymisiert, Diverse
11/2018 – offen (2 Jahre, 5 Monate)
Various industries

11/2018 – offen


Helping clients to ideate, define, challenge and implement strategies, business models, target operating models, technologies and implementation roadmaps in order to master the challenges of Digital Transformation, the Internet of Things, Industry 4.0 topics, and relevant underlying or related technologies, such as Robotics, Factory Automation, Machine Learning, Cloud, etc.

Facilitating and leveraging methodologies and strategies such as Design Thinking, Innovation & Knowledge Management, Human-Centered Design, Customer Journey etc, to create awareness and build up momentum for implementing a truly Digital Culture throughout the entire organization, as an indispensable precondition of successful Digital Transformation.

Eingesetzte Qualifikationen


Global Program Manager Connectivity Solutions (Festanstellung)
Belimed AG, Zug
5/2016 – 10/2018 (2 Jahre, 6 Monate)

5/2016 – 10/2018


Global lead of the Connectivity Solutions program, which is Belimed’s effort to bundle all ideas, resources, assets, R&D activities, and client solutions relating to the company’s digital transformation under a joint oversight and governance body responsible for coordinated planning, management, and project execution, in order to maximize efficiency and synergies, and to minimize overhead and duplicate work. The CS Program serves to align Belimed’s digital transformation efforts with the digital strategy of corporate group management. It is an expression of the company’s belief that the future of healthcare in general, and medical devices in particular, is digital and connected, and emphasizes Belimed’s commitment to be at the forefront of the digital revolution and a leader in the digital transformation in healthcare.

Eingesetzte Qualifikationen

Internet / Intranet- Integration (eBusiness), Prozess- / Workflow, Requirement Analyse, Compliance management, Prozessmanagement, Risikomanagement, Mehrprojektmanagement, Programm Management, Fehlermöglichkeits- und -einflussanalyse (FMEA), Qualitätsmanagement (allg.), Prozessberatung, Produktmanagement, Product-lifecycle-management (PLM)

Head of Organizational Excellence (Festanstellung)
CynetiX GmbH, Bern
1/2008 – 4/2016 (8 Jahre, 4 Monate)

1/2008 – 4/2016


Consulting auf den Gebieten Qualitätsmanagement, Risikomanagement, Regulatory Affairs Management, Governance, Compliance. Interims-Management, Strategische Programm- und Projektleitung.

Eingesetzte Qualifikationen

IT-Strategieberatung, Compliance management, Risikomanagement, Mehrprojektmanagement, Programm Management, Projektmanagement, Qualitätsmanagement (allg.), Corporate Governance

Projektmanagement, Qualitätsmanagement, Governance & Strategie Consulting
Diverse, Diverse
1/2000 – 12/2007 (8 Jahre)
Diverse Branchen (u.a. Automobil, Finanzen, Schienenverkehr, Telekommunikation, Verteidigung)

1/2000 – 12/2007


Freiberufliche Beratertätigkeit in diversen Branchen und Fachbereichen. Weitere Info auf Anfrage.

Eingesetzte Qualifikationen

Projektmanagement (IT), Projektleitung / Teamleitung (IT), Qualitätsmanagement / QS / QA (IT), System Design, System Architektur, System Analyse, Requirement Analyse, Machbarkeitsanalyse, IT-Strategieberatung, IT-Beratung (allg.), Technisches Qualitätsmanagement / QS / QA, Fehlermöglichkeits- und Einfluss-Analyse (FMEA / FMECA), Projektmanagement, Enterprise project management (EPM), Qualitätsmanagement (allg.)

Projektmanagent, Qualitätamanagement, Regulatory Affairs & Compliance (Festanstellung)
Siemens Medical Solutions, Hoffman Estates
9/1991 – 12/1999 (8 Jahre, 4 Monate)
High-Tech- und Elektroindustrie

9/1991 – 12/1999


PSG member in development of a Medical Imaging (PACS) Online Archive

* Member of the international PSG (Project Steering Group), serving the roles of project manager and quality manager for system design & architecture throughout the entire SDLC according to GMP regulations.
* Coordinated development and engineering tasks between German, U.S., and Swedish locations.
* Designed the system architecture from scratch for hardware, software, and infrastructure.
* Designed the data model, and supervised DBMS setup, configuration, and performance tuning of the object-oriented Versant database.
* Worked closely with the engineering team during implementation of the prototype, integration, performance, and quality tests. Handled change request management.
* Wrote 510(k) & GMP compliant documentation, including Requirements Specification, System Analysis Specification, System Design Specification, System Engineering Specification, and System Maintenance Specification.
* Accompanied analysis and definition of use cases, and authoring of System Administration Manual and Clinical User Manual. Prepared and supervised prototype implementation and authoring of documentation as QM for FDA auditing.
* Coordinated communications between distributed developer teams in Germany, the U.S., Sweden, and India. Organized and drove information flow from DICOM task force and developer team of the PACS class library (pre-Syngo product) to the ACOM.Net developer teams.
* Worked closely with clinical users during design & implementation phase, drove and supervised installation and operation of prototypes at hospitals, taking part in clinical trial tests (St. Mary’s Hospital Chicago, German Heart Disease Center Munich, Heart Disease Research Center Bad Oeynhausen).
* Close involvement with working out the product development roadmap, upgrade & replacement roadmap. Managed QM/QA on cost analysis & budgeting, throughout all phases of the project.
* Accompanied early adopter clinical clients during product introduction as aftersales technical manager, providing the clients a direct link to 3rd level technical support and engineering.

Eingesetzte Qualifikationen

Klinische Studie, FMEA (Failure Mode and Effects Analysis), FMECA (Failure Mode and Effects and Criticality Analysis), Machbarkeitsanalyse, Requirement Analyse, Compliance management, Risikomanagement, Projektmanagement, Qualitätsmanagement (allg.), Medizintechnik / Labortechnik

Technology Specialist (Festanstellung)
German Armed Forces, Deutschland & USA
9/1989 – 8/1991 (2 Jahre)

9/1989 – 8/1991


Technology Specialist

Eingesetzte Qualifikationen

Netzwerktechnik, Ortungstechnik, Radartechnik, Satellitentechnik / Satellitenkommunikation


Project Management, Management Information Systems
(extra-curricular coursework)
Jahr: 2000
Ort: University of California, San Diego
Psychology, Computer Science
(extra-curricular coursework)
Jahr: 1999
Ort: Loyola University, Chicago
Philosophie, Politikwissenschaft, Informatik
(ZP, im lieu B.A.)
Jahr: 1996
Ort: Erlangen



Über mich


Part nerd, part explorer, part critical observer, I’m passionate about every aspect and application of digital technology and the endless possibilities it could and hopefully will bring about for the benefit of humanity. I consider myself having been a digital native decades before the term was coined, but also had a strong affinity with the life science industry since early in my professional career.

I am dedicated to driving digital transformation by applying a holistic and systemic approach to change, not focused on technology alone, but rather encompassing every aspect of transformation, with people and culture being at its very center.

Having a broad international education and work experience in different corners of the world, including North America, Europe, Africa, and Oceania, I consider myself being a global citizen and feel at home wherever I find like-minded people and a liberating atmosphere of open-mindedness, curiosity, and willingness to venture off the beaten paths and advance into uncharted territory. I am relentlessly striving to pull in an ever increasing number of crusaders in my mission to create a truly digital mindset, unshakably ingrained in people’s hearts and minds.

Being a strictly value driven person, I do, and always will, put values, people and human interaction over numbers, structures and processes, and I expect the very same from a potential employer. I firmly believe in the ultimate truth contained in a quote attributed to Richard Branson, that “Success in business is all about people, people, people. Whatever industry a company is in, its employees are its biggest competitive advantage.”

I’m an avid evangelist of the Agile Manifesto and the mindset it stands for, of leveraging the benefits of intrinsic motivation (versus the vain belief in exercising control over people), of cooperative collaboration regardless of position and role (versus archaic hierarchies), of small, flexible, self-organizing teams of subject matter experts (versus cumbersome line organization behemoths), and of the steadfast conviction (paraphrasing Victor Hugo) that...

...nothing is stronger than an idea whose time has come.

Persönliche Daten

  • Englisch (Muttersprache)
  • Deutsch (Muttersprache)
auf Anfrage
  • Europäische Union
  • Schweiz
29 Jahre und 6 Monate (seit 09/1991)
20 Jahre


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