freiberufler Senior Medical Consultant auf freelance.de

Senior Medical Consultant

zuletzt online vor wenigen Tagen
  • 80‐110€/Stunde
  • 2161 Csomad
  • Europa
  • hu  |  en  |  de
  • 01.10.2024

Kurzvorstellung

I am working on the medical field 10+ years.I worked as Development Engineer, Development Project manager, Engineering Manager, and recently I am working as a consultant on Sterilisation, Sterile packaging and Validation&Verification (V&V) projects.

Auszug Referenzen (2)

"B. T. has been a key support in defining a new sterilisation and sterile packaging assurance concept."
MDR Remediation Specialist – Sterilisation and sterile packaging
Kundenname anonymisiert
Tätigkeitszeitraum

2/2022 – 9/2023

Tätigkeitsbeschreibung

Gap analysis for sterilisation and sterile packaging
Coordinate the sterile barrier system developments
Risk analysis of the sterilisation and sterile barrier system
Define the sterilisation strategy of new products
Prepare the sterilisation and sterile packaging process validation plan
Prepare the sterilisation and sterile packaging Design Verification plan
Create sterile packaging standard implementations and summary document
Coordinate sterilisation and sterile packaging validation and verification
Define the packaging test methods and create test descriptions
2
Define the proper machines and tools for packaging tests
Calculate the EO residual limits after sterilisation for new products
Define microbiological limits (CFU limits) for new products
Define endotoxin test frequency and limits
Define physical contamination test frequency and limits

Eingesetzte Qualifikationen

Ingenieurwissenschaft, DIN EN ISO 13485, Verpackung und Kennzeichnung

"It is easy to work with Balázs.
Balázs' main strengths:
- diverse knowledge
- manliness
- helpfulness
- result orientation
- professionalism"
Deputy – Head of Development Center (Festanstellung)
Jozsef Szarvas
Tätigkeitszeitraum

9/2018 – 10/2019

Tätigkeitsbeschreibung

R&D responsible for wound drainage and suction devices
Substitute of the Head of Development Center in his absence
R&D responsible for medical device packages, whole portfolio produced on site
Coordinate projects, capacities and delegate tasks within the R&D group

Eingesetzte Qualifikationen

DIN EN ISO 13485, Verpackungstechnik, Ingenieurwissenschaft

Qualifikationen

  • ASTM F1980
  • Design Verification
  • DIN EN ISO 134856 J.
  • ISO 10993
  • ISO 11607
  • ISO11135
  • ISO11137
  • Prozessvalidierung1 J.
  • Sterilisation
  • Verpackung und Kennzeichnung2 J.

Projekt‐ & Berufserfahrung

Bench Testing, Design Verification
Implantica, Zug
8/2023 – 1/2024 (6 Monate)
Life Sciences
Tätigkeitszeitraum

8/2023 – 1/2024

Tätigkeitsbeschreibung

Gap analysis of sterile barrier system
Prepare the sterile barrier system bench testing plan: including extreme
environmental conditioning, shipment simulation, packaging and functional tests
Define the necessary unique distribution cycle (DC 2 according to ASTM D4169)
proper for the planned logistics
Define climate conditioning parameters depending on target market
Create sterile packaging standard implementations and summary document
Coordinate the bench testing process.
Define the packaging test methods and create test descriptions

Eingesetzte Qualifikationen

DIN EN ISO 13485, Prozessvalidierung, Verpackung und Kennzeichnung

MDR Remediation Specialist – Sterilisation and sterile packaging
Ypsomed AG, Solothurn
2/2022 – 9/2023 (1 Jahr, 8 Monate)
Life Sciences
Tätigkeitszeitraum

2/2022 – 9/2023

Tätigkeitsbeschreibung

Gap analysis for sterilisation and sterile packaging
Coordinate the sterile barrier system developments
Risk analysis of the sterilisation and sterile barrier system
Define the sterilisation strategy of new products
Prepare the sterilisation and sterile packaging process validation plan
Prepare the sterilisation and sterile packaging Design Verification plan
Create sterile packaging standard implementations and summary document
Coordinate sterilisation and sterile packaging validation and verification
Define the packaging test methods and create test descriptions
2
Define the proper machines and tools for packaging tests
Calculate the EO residual limits after sterilisation for new products
Define microbiological limits (CFU limits) for new products
Define endotoxin test frequency and limits
Define physical contamination test frequency and limits

Eingesetzte Qualifikationen

Ingenieurwissenschaft, DIN EN ISO 13485, Verpackung und Kennzeichnung

Engineering Manager (Festanstellung)
Medicontur Ltd., Zsambek
10/2020 – 2/2022 (1 Jahr, 5 Monate)
Life Sciences
Tätigkeitszeitraum

10/2020 – 2/2022

Tätigkeitsbeschreibung

Coordinate the daily work of the engineering and maintenance team (10 employees)
Ensure continuous production
Improve manufacturing process, implement LEAN concepts
Validation of new processes and equipment
NPI – transfer newly developed products/machines into the production

Eingesetzte Qualifikationen

DIN EN ISO 13485, Verpackungstechnik, Management (allg.)

Consultant and Business Analyst (Festanstellung)
Asseco Central Europe H., Budapest
10/2019 – 10/2020 (1 Jahr, 1 Monat)
IT & Entwicklung
Tätigkeitszeitraum

10/2019 – 10/2020

Tätigkeitsbeschreibung

Optimisation of production process with plant simulation software
Real Time monitoring of material flow and production
Simulation, implementation and monitoring of material handling with AGVs
Clarify relevant customer requirements about the product
Market research for possible customers

Eingesetzte Qualifikationen

Business Analysis

Deputy – Head of Development Center (Festanstellung)
BBraun, Melsungen
9/2018 – 10/2019 (1 Jahr, 2 Monate)
Life Sciences
Tätigkeitszeitraum

9/2018 – 10/2019

Tätigkeitsbeschreibung

R&D responsible for wound drainage and suction devices
Substitute of the Head of Development Center in his absence
R&D responsible for medical device packages, whole portfolio produced on site
Coordinate projects, capacities and delegate tasks within the R&D group

Eingesetzte Qualifikationen

DIN EN ISO 13485, Verpackungstechnik, Ingenieurwissenschaft

Development Project Manager (Festanstellung)
BBraun, Melsugen
9/2016 – 9/2018 (2 Jahre, 1 Monat)
Life Sciences
Tätigkeitszeitraum

9/2016 – 9/2018

Tätigkeitsbeschreibung

found in reference description 5
R&D responsible for wound drainage and suction devices
R&D responsible for medical devices packages produced on site
Packaging optimisation – define new materials, harmonise current portfolio
 Coordination of packaging Process Validations and Design Verification based on ISO
11607-1/2
Development of new, crystal clear drain bottles with tube set to the US market
Supplier Audit – external lab
Ensure the clean water supply for production
Define frequency of testing and the sampling points of the clean water system
Prepare URS for new production equipment
Revise specifications and drawings of supplier.

Eingesetzte Qualifikationen

DIN EN ISO 13485, Ingenieurwissenschaft, SAP CRM, Verpackungstechnik

Development Engineer
BBraun, Melsungen
9/2015 – 9/2016 (1 Jahr, 1 Monat)
Life Sciences
Tätigkeitszeitraum

9/2015 – 9/2016

Tätigkeitsbeschreibung

R&D responsible for wound drainage and suction devices
Development of new, crystal clear drain bottles to the US market
Implement new back check valve to drain bottles
Revise specifications and drawings of supplier
Verification of new components from alternative supplier

Eingesetzte Qualifikationen

Ingenieurwissenschaft, Verpackungstechnik

Ausbildung

Economist in Management and LEadership
MSC in Economics
Budapest Business School
2023
Budapest
Master Diplom - Mechanical Engineer
Mechanical Engineer
Budapest Univercity of Technology and Economics
2016
Budapest
Mechatronical Engineer
2014
Budapest University of Technology and Economics
2014
Budapest

Über mich

I have several years experiences in the developemnt of active and non-active medical devices and medical implants. I usually work in international teams, for Swiss and German companies. I am involved in R&D, QA and RA teams to support their packaging and sterilisation activities, to support their new product registration in US and EU, prepare proper documentation for authorities, to fulfill FDA and MDR requirements.

Weitere Kenntnisse

found in profile qualification
Certificates and trainings:
▪ ISO 13485; ISO 13485 – internal auditor
▪ Medical device packaging (ISO 11607-1 and -2; ASTM F1980, ASTM F1886,
ASTM1929, ASTM F88, ASTM F2096, EN 868-5, EN 868-10)
▪ Transport simulation (ASTM D4169)
▪ Microbiology and sterile barrier system (ISO 15378, DIN-58953-6; DIN EN ISO 10993-
1, ISO 10993-5, ISO 10993-7)
▪ Sterilisation (EN ISO 11737-1 and -2; EN 14644; EN 556-1 and -2; ISO 11135; EN ISO
14161)
▪ Member of the organisation: ASTM (American Society for Testing and Materials)
▪ Project management
▪ 4DX and 7 Habits (Franklin Covey)
▪ EU Directives (93/42/EEC, 98/79/EC and 90/385/EEC) (MDD)
▪ Regulation (EU) 2017/745 (MDR)
▪ Agile project management

Persönliche Daten

Sprache
  • Ungarisch (Muttersprache)
  • Englisch (Fließend)
  • Deutsch (Fließend)
Reisebereitschaft
Europa
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Home-Office
bevorzugt
Profilaufrufe
288
Alter
33
Berufserfahrung
9 Jahre und 1 Monat (seit 09/2015)
Projektleitung
5 Jahre

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