Owner, Project Management, Design Control Specialist and Regulatory Affairs for Medical Devices
Owner, Project Management, Design Control Specialist and Regulatory Affairs for Medical Devices
Managing the complete project including R&D main specification and the setup of the entire life cycle. The targeted device was an ECG monitor (class IIa). (Germany)
General project planning
GAP analysis
Design control documentation
Design review plans
Validation and verification plans
ISO 62304
ISO 14971
Building up a (reverse engineering) documentation package according to the MDR. The targeted device was an UroFlowmeter (class Im). (Germany)
GAP analysis
Design control documentation
Design review plans
Validation and verification plans
ISO 62304
ISO 14971
IEC 62366
Building up the project documentation package according to the MDR. The targeted device was a Urodynamic device (class IIa). (Germany)
GAP analysis
Design control documentation
ISO 62304
ISO 14971
IEC 62366
Building up a (reverse engineering) documentation package according to the MDR. The targeted device was a Cone Beam Computed Tomography device (CBCT 3D XRAY) (class IIb). (Germany)
GAP analysis
Design control documentation
Design review plans
Validation and verification plans
ISO 62304
ISO 1497
IEC 62366
As the Technical Director, building up a medical IoT concept including BLE and LTE Cat M1 communication. The targeted device was a wearable Holter light weight ECG device for long time recording with RF communication for immediate patient diagnosis (class IIa). (Sweden)
GAP analysis
R&D device design concept
HW requirement specification
HW design specification
Design control documentation
ISO 62304
ISO 14971
Supporting a project team with doing IVD gap analysis and writing IVDR STED file chapters for final RA submission to a notified body. Setting up an Indian consultancy team including project management (labeling). The targeted devices were standalone network connected Hospital Laboratory Blood Gas Analyzers.
(Denmark/India)
General GAP analysis for the blood gas analyzers
Electrical Safety and Electromagnetic Compatibility
IEC 61010
IEC 61326
Supporting a project team writing and extending various documentation according to the MDR. (Denmark/US)
Design Verification test documents
Working with one of the company?s US units on test protocols and Danish local Quality Engineering
Design Input Requirements (DIR)
General Safety and Performance Requirements Checklist (GSPR)
The targeted device was a Vena Cava Blood Clot Filter Retrieval System, including catheters, dilators, and retrieval unit (class III). Various catheter and dilator standards etc.
ISO 25539
ISO 11070
ISO 10555
As a Design Control Specialist supporting a large-scale remediation project generating and extending various documentation according to the MDR. (Denmark/US/UK)
Design and Development Plans
Design Input & Traceability Matrix
Design Verification Plans
Product Claims Tables
BOM Verification´s
The targeted devices were infusion sets, mainly for insulin (class IIb). Various infusion set and catheter standards etc.
ISO 8536
ISO 11070
As a RA Officer supporting a large-scale MDR project generating and extending various documentation according to the MDR. (Belgium/Germany)
STED file
General Safety and Performance Requirements Checklist (GSPR)
Review/update List of Applicable Standards
Review/update UFMEA, DFMEA, PFMEA
The targeted devices were Copper Intrauterine Devices (IUD) for contraception, (class III). Various IUD and other medical standards applied.
ISO 7439
ISO 14630
ISO 20417
ISO 15223
on request
Germany
24 Jahre 5 Monate
2000-11 - heute
Applications Engineering EMEA / FAE
Manager
Manager
Building strategic relationships with leading mobile phone manufacturers being an integrated part of sales & marketing
Flash memory cards, Secure Flash memory cards
Key account support
Design-in?s, product qualifications and product transitions
Responsible for strategic relationships and reference design activities at the key EMEA mobile phone infrastructure providers
Representative within standardization bodies
Special medical treatment quality assurance projects for medical devices
SanDisk GmbH
Germany
1 Jahr
2009-01 - 2009-12
WW Technical Marketing, Corporate Engineering
Director
Director
Responsible for initiating and maintaining a Competitive Analysis Program
Market Intelligence
Compiling documentation for customer interaction, mainly for Sales
Management reporting
Implementation of test facility in India
Coaching and final project handover
Responsible for team of 5 people
?Munich, Milpitas, Bangalore
SanDisk GmbH
Munich, Milpitas, Bangalore
2 Jahre
2007-01 - 2008-12
WW Technical Marketing, Mobile Retail Business Unit
Director
Director
Building strategic relationships with mobile network operators and mobile phone vendors
Market intelligence
Responsible for team of 10 people
?Munich, Milpitas, Shanghai, Paris
SanDisk GmbH
Munich, Milpitas, Shanghai, Paris
2 Jahre 5 Monate
1998-06 - 2000-10
WW Applications Engineering MultiMediaCard
Manager
Manager
Core member of the MultiMediaCard team
Building up a support and software tool environment for MultiMediaCard products (Flash memory cards)
Building strategic relationship with Hitachi in Japan
Flash memory cards
WW key account support
Design-in of memory cards in high volume phones
Project related support of BD and marketing
Focus on automotive, early infotainment systems
Representative within standardization bodies
?MultiMediaCard / SecureDigital Associations
Infineon Technologies AG
Germany
2 Jahre
1996-07 - 1998-06
Definition of devices for diagnosis
Project Manager
Project Manager
Definition of devices for diagnosis of erectile dysfunction?s
Definition and controlling of external development projects
Production cost reduction project
Controlling of US (510k) and Japanese (PMDA) class IIa equipment approvals
ANDROMEDA medizinische Systeme GmbH
Germany
6 Jahre 5 Monate
1990-02 - 1996-06
Development of multi processor platforms
R&D Engineer, Project Manager
R&D Engineer, Project Manager
R&D Engineer
Development of multi processor platforms for cardiac emergency units
Real-time multitasking programming in C and C++ including risk analysis and validation and verification
semiautomatic defibrillators, software algorithm?s for ventricular fibrillation detectors
Project Manager
Product approvals for medical devices, BSI, TÜV
Working out concepts for future products
Supervisor (MS Windows and Novell Netware)
GS-Elektromedizinische Geräte GmbH
Germany
4 Jahre 7 Monate
1985-07 - 1990-01
Development of high risk medical devices
R&D Engineer, Project Manager
R&D Engineer, Project Manager
R&D Engineer
Development of high risk medical devices
Development of controller boards for defibrillators and cardiac pacemakers
Real-time multitasking programming in C and Assembler including risk analysis and validation and verification
Regulatory AffairsDesign Control SpecialistProjektleitungDesign/Entwicklung/KonstruktionDesign Input MatrixDesign SpecificationExtended Standards Experience
Produkte / Standards / Erfahrungen / Methoden
Profile
The Freelancer is an accomplished entrepreneurial leader and innovator with twenty-five years+ of experience within R&D projects including reverse engineering in global organizations in the areas of both medical and semiconductor. These efforts were aligned to business targets of each specific company.
He has hands-on experience in MDR/IVDR, Design Input Requirements, GSPR, STED, Concept Engineering and Product Specification.
He has a pragmatic and constructive approach and believes that results are best achieved in a straightforward open minded dialogue between the parties.
The Freelancer has experience in overviewing the entire structure of a company and can integrate himself quickly into new environments.
My own consultancy firm was founded in 2010.
Einsatzorte
Einsatzorte
München (+500km)
Deutschland, Schweiz, Österreich
möglich
Projekte
Projekte
15 Jahre
2010-04 - heute
various Projects
Owner, Project Management, Design Control Specialist and Regulatory Affairs for Medical Devices
Owner, Project Management, Design Control Specialist and Regulatory Affairs for Medical Devices
Managing the complete project including R&D main specification and the setup of the entire life cycle. The targeted device was an ECG monitor (class IIa). (Germany)
General project planning
GAP analysis
Design control documentation
Design review plans
Validation and verification plans
ISO 62304
ISO 14971
Building up a (reverse engineering) documentation package according to the MDR. The targeted device was an UroFlowmeter (class Im). (Germany)
GAP analysis
Design control documentation
Design review plans
Validation and verification plans
ISO 62304
ISO 14971
IEC 62366
Building up the project documentation package according to the MDR. The targeted device was a Urodynamic device (class IIa). (Germany)
GAP analysis
Design control documentation
ISO 62304
ISO 14971
IEC 62366
Building up a (reverse engineering) documentation package according to the MDR. The targeted device was a Cone Beam Computed Tomography device (CBCT 3D XRAY) (class IIb). (Germany)
GAP analysis
Design control documentation
Design review plans
Validation and verification plans
ISO 62304
ISO 1497
IEC 62366
As the Technical Director, building up a medical IoT concept including BLE and LTE Cat M1 communication. The targeted device was a wearable Holter light weight ECG device for long time recording with RF communication for immediate patient diagnosis (class IIa). (Sweden)
GAP analysis
R&D device design concept
HW requirement specification
HW design specification
Design control documentation
ISO 62304
ISO 14971
Supporting a project team with doing IVD gap analysis and writing IVDR STED file chapters for final RA submission to a notified body. Setting up an Indian consultancy team including project management (labeling). The targeted devices were standalone network connected Hospital Laboratory Blood Gas Analyzers.
(Denmark/India)
General GAP analysis for the blood gas analyzers
Electrical Safety and Electromagnetic Compatibility
IEC 61010
IEC 61326
Supporting a project team writing and extending various documentation according to the MDR. (Denmark/US)
Design Verification test documents
Working with one of the company?s US units on test protocols and Danish local Quality Engineering
Design Input Requirements (DIR)
General Safety and Performance Requirements Checklist (GSPR)
The targeted device was a Vena Cava Blood Clot Filter Retrieval System, including catheters, dilators, and retrieval unit (class III). Various catheter and dilator standards etc.
ISO 25539
ISO 11070
ISO 10555
As a Design Control Specialist supporting a large-scale remediation project generating and extending various documentation according to the MDR. (Denmark/US/UK)
Design and Development Plans
Design Input & Traceability Matrix
Design Verification Plans
Product Claims Tables
BOM Verification´s
The targeted devices were infusion sets, mainly for insulin (class IIb). Various infusion set and catheter standards etc.
ISO 8536
ISO 11070
As a RA Officer supporting a large-scale MDR project generating and extending various documentation according to the MDR. (Belgium/Germany)
STED file
General Safety and Performance Requirements Checklist (GSPR)
Review/update List of Applicable Standards
Review/update UFMEA, DFMEA, PFMEA
The targeted devices were Copper Intrauterine Devices (IUD) for contraception, (class III). Various IUD and other medical standards applied.
ISO 7439
ISO 14630
ISO 20417
ISO 15223
on request
Germany
24 Jahre 5 Monate
2000-11 - heute
Applications Engineering EMEA / FAE
Manager
Manager
Building strategic relationships with leading mobile phone manufacturers being an integrated part of sales & marketing
Flash memory cards, Secure Flash memory cards
Key account support
Design-in?s, product qualifications and product transitions
Responsible for strategic relationships and reference design activities at the key EMEA mobile phone infrastructure providers
Representative within standardization bodies
Special medical treatment quality assurance projects for medical devices
SanDisk GmbH
Germany
1 Jahr
2009-01 - 2009-12
WW Technical Marketing, Corporate Engineering
Director
Director
Responsible for initiating and maintaining a Competitive Analysis Program
Market Intelligence
Compiling documentation for customer interaction, mainly for Sales
Management reporting
Implementation of test facility in India
Coaching and final project handover
Responsible for team of 5 people
?Munich, Milpitas, Bangalore
SanDisk GmbH
Munich, Milpitas, Bangalore
2 Jahre
2007-01 - 2008-12
WW Technical Marketing, Mobile Retail Business Unit
Director
Director
Building strategic relationships with mobile network operators and mobile phone vendors
Market intelligence
Responsible for team of 10 people
?Munich, Milpitas, Shanghai, Paris
SanDisk GmbH
Munich, Milpitas, Shanghai, Paris
2 Jahre 5 Monate
1998-06 - 2000-10
WW Applications Engineering MultiMediaCard
Manager
Manager
Core member of the MultiMediaCard team
Building up a support and software tool environment for MultiMediaCard products (Flash memory cards)
Building strategic relationship with Hitachi in Japan
Flash memory cards
WW key account support
Design-in of memory cards in high volume phones
Project related support of BD and marketing
Focus on automotive, early infotainment systems
Representative within standardization bodies
?MultiMediaCard / SecureDigital Associations
Infineon Technologies AG
Germany
2 Jahre
1996-07 - 1998-06
Definition of devices for diagnosis
Project Manager
Project Manager
Definition of devices for diagnosis of erectile dysfunction?s
Definition and controlling of external development projects
Production cost reduction project
Controlling of US (510k) and Japanese (PMDA) class IIa equipment approvals
ANDROMEDA medizinische Systeme GmbH
Germany
6 Jahre 5 Monate
1990-02 - 1996-06
Development of multi processor platforms
R&D Engineer, Project Manager
R&D Engineer, Project Manager
R&D Engineer
Development of multi processor platforms for cardiac emergency units
Real-time multitasking programming in C and C++ including risk analysis and validation and verification
semiautomatic defibrillators, software algorithm?s for ventricular fibrillation detectors
Project Manager
Product approvals for medical devices, BSI, TÜV
Working out concepts for future products
Supervisor (MS Windows and Novell Netware)
GS-Elektromedizinische Geräte GmbH
Germany
4 Jahre 7 Monate
1985-07 - 1990-01
Development of high risk medical devices
R&D Engineer, Project Manager
R&D Engineer, Project Manager
R&D Engineer
Development of high risk medical devices
Development of controller boards for defibrillators and cardiac pacemakers
Real-time multitasking programming in C and Assembler including risk analysis and validation and verification
Regulatory AffairsDesign Control SpecialistProjektleitungDesign/Entwicklung/KonstruktionDesign Input MatrixDesign SpecificationExtended Standards Experience
Produkte / Standards / Erfahrungen / Methoden
Profile
The Freelancer is an accomplished entrepreneurial leader and innovator with twenty-five years+ of experience within R&D projects including reverse engineering in global organizations in the areas of both medical and semiconductor. These efforts were aligned to business targets of each specific company.
He has hands-on experience in MDR/IVDR, Design Input Requirements, GSPR, STED, Concept Engineering and Product Specification.
He has a pragmatic and constructive approach and believes that results are best achieved in a straightforward open minded dialogue between the parties.
The Freelancer has experience in overviewing the entire structure of a company and can integrate himself quickly into new environments.
My own consultancy firm was founded in 2010.
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Im Bereich Freelancing
Im Bereich Arbeitnehmerüberlassung / Personalvermittlung