Profilbild von Stefan Schwarzbach Senior Medical Device R&D, Regulatory and Executive Consultant aus Wessling

Stefan Schwarzbach

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Letztes Update: 22.04.2023

Senior Medical Device R&D, Regulatory and Executive Consultant

Firma: Stefan Schwarzbach Technical Consulting
Abschluss: Dipl.-Informatik Univ.
Stunden-/Tagessatz: anzeigen
Sprachkenntnisse: deutsch (Muttersprache) | englisch (verhandlungssicher) | französisch (Grundkenntnisse)

Dateianlagen

cv-stefan-schwarzbach_220423.pdf

Skills

Management:
+ Developing and improving company's engineering strategies
+ Technical Business development
+ Bulding up and management of engineering teams
+ Communication, motivation and conflict resolution
+ Mentoring with hands-on mentality

Project Management
+ Project Management (Agile, Traditional)
+ Project Controlling
+ Overall understanding of high-risk medical devices

Software Engineering :
+ Development of Concepts
+ Architecture Design
+ Implementation / Development
+ Testing
+ Release- , Change- and Configuration Management
+ Medical Device Software Development (IEC 62304)
+ Embedded software development
+ Wireless systems

Hardware Engineering:
+ Medical Device Hardware Development (IEC 60601)
+ Schematics & Layout
+ Testing

Quality Management & Regulatory Affairs:
+ Development of quality management systems
+ Internal auditor
+ Supervise external audits
+ Risk Management
+ Supervise regulatory affairs

Projekthistorie

07/2019 - bis jetzt
Senior Engineering Consultant
Syntach AB (Pharma und Medizintechnik, 10-50 Mitarbeiter)

Responsible for the development of hardware and firmware for an active medical implant and body worn components in the area of cardiac support.
Activities:
- Project coordination and planning
- Hardware / Electronics development
- Firmware development
- Design documentation, regulatory consulting
- Coordination of suppliers
- Transition of design to production

01/2019 - bis jetzt
Senior Engineering Consultant
LivaNova (Pharma und Medizintechnik, 1000-5000 Mitarbeiter)

Software development, documentation, testing
• Development of firmware for ARM using Eclipse
• Development of application test software using C#/.Net
• Definition and implementation of the integration and acceptance tests

04/2014 - bis jetzt
Senior Engineering Consultant
Sequana Medical NV (Pharma und Medizintechnik, 50-250 Mitarbeiter)

Responsible for the development of hardware and firmware for an active medical implant and body worn components in the area of fluid overload support.
Activities:
- Project coordination and planning
- Hardware / Electronics development
- Firmware development
- Software development
- Design documentation, regulatory consulting
- Coordination of suppliers
- Transition of design to production

07/2021 - 08/2022
Senior Engineering Consultant
Longeviti Neuro Solutions (Pharma und Medizintechnik, 50-250 Mitarbeiter)

Responsible for the development of a wireless energy transmission system for an active neuro / cranial implant.
Key Activities:
- Project coordination
- Hardware / Electronics development
- Wireless Energy Transfer simulations
- Coordination of suppliers
- Prototype testing

03/2012 - 02/2019
Chief Technical Officer (CTO)
Dualis MedTech GmbH (Pharma und Medizintechnik, 10-50 Mitarbeiter)

Running all technical aspects including business development of a company providing engineering services and core technologies to medical device companies

07/2014 - 02/2018
CEO / Founder / Shareholder
Ingenio Solutions GmbH (Pharma und Medizintechnik, < 10 Mitarbeiter)

Development, Manufacturing and Sales of innovative products in the area of medical devices and consumer electronics.

12/2007 - 02/2011
Software Development Consultant
Online Programmierung GmbH (Telekommunikation, < 10 Mitarbeiter)


08/2004 - 12/2008
CEO / Founder
Silent Dreams (Sonstiges, < 10 Mitarbeiter)

Leading activities in software development, business development and financing

10/2004 - 10/2007
Research and Development Specialist
German National Aerospace Agency (DLR) (>10.000 Mitarbeiter)


10/2003 - 08/2004
Research Consultant
Technical University of Munich


Reisebereitschaft

In der Stadt Weßling mit einem Radius von 250 km verfügbar
Profilbild von Stefan Schwarzbach Senior Medical Device R&D, Regulatory and Executive Consultant aus Wessling Senior Medical Device R&D, Regulatory and Executive Consultant
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