Professional experience -medical device industry R&D and Regulatory ISO 13485
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- Weltweit
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- 18.11.2021
Kurzvorstellung
Qualifikationen
Projekt‐ & Berufserfahrung
8/2016 – offen
Tätigkeitsbeschreibung
Heading R&d- Developing advanced wound dressing, silver based post operative wound dressing, Ulcer wound dressing, orthopaedic products
Regulatory- Regulatory documentation, Usability engineering, Design control files, Risk management reports, Device master files, CE certification documentation (class 3 product) , Clean room manufacturing,
Technical support to marketing- Conducting CME (continuous medical education programmes all over India), 50 talks to doctors and hospital administrations and other clinical experts, product registration in Asian countries
Technology transfer- Industry and academic research institutes cooperation and technology transfer
FMEA (Failure Mode and Effects Analysis), Forschung & Entwicklung, Regulatory Affairs, Technischer Support, Technisches Testing
7/2014 – 8/2015
Tätigkeitsbeschreibungteaching systems engineering (Materials and Hardware ) to engineering students and conducting practicals.
Eingesetzte QualifikationenLehrprogramme
12/2013 – 7/2014
TätigkeitsbeschreibungIndustrial projects trouble shooting, formulation issues resolving, testing and characterization- report to industry
Eingesetzte QualifikationenProjekt - Berichtswesen, Technischer Support, Werkstoffprüfung
1/2005 – 5/2013
Tätigkeitsbeschreibung
R&D scientific worker/ product application manager, Antimicrobial polymer formulation development, Testing (mechanical properties, chemical analysis) and processing and development of new formulation , biological testing, technical support to marketing,
Trouble shooting , Technical documentation
Analytische Chemie, Forschung & Entwicklung, Prüftechnik (allg.), Technische Dokumentation, Technischer Support
3/2002 – 12/2004
Tätigkeitsbeschreibung
Responsibilities: Research on the development of silver based antimicrobial biomaterial composites using various types of silver biocides, Quantitation (inverse voltammetry) of silver ion release from polymer composites produced from metallic silver and silver filled additives (glass, ceramic, zeolite based) and polymers (Polyamide, Poly Ethylene, Polypropylene and elastomers). writing project reports for submission to the European Union. Optimization of processing conditions, antimicrobial properties, testing and characterization (Infra Red spectrum, DSC, DMTA, TGA, SEM, SEM-EDS, UTM (Universal Testing Machine for mechanical properties), Electrochemical analysis. Correlation of electrochemical kinetics data with biological efficacy.
Compilation of half yearly project reports to European Union and work progress presentation in semi-annual project meetings.
Supervising guide: Responsible for practicals for engineering students and supervised project thesis for students (Materials science and Engineering)
Analytische Chemie, Forschung & Entwicklung, Projektleitung / Teamleitung (IT), Materialwissenschaft und Werkstofftechnik, Werkstoffprüfung
1/2001 – 12/2001
Tätigkeitsbeschreibung
Project related to Polymer recycling . developed Processing sstrategies for polymer recycling, Rubber Technology, developed novel Polymer Composites. Recycling of ground tire rubber and polyurethane wastes as potential fillers in thermoplastics and elastomers. Structure property relationship. Rubber compounding and plastic extrusion.
As a postdoctoral research fellow in IVW gained a lot of research experience in analytical methods, testing and characterisation (e.g. UTM, DSC, TGA, SEM, AFM, DMTA, Plate/plate rheometry.
Kunststoffverfahrenstechnik, Naturwissenschaft, Recycling / Abfallverwertung
Zertifikate
Ausbildung
Erlangen, Eermany
Über mich
Very good experience in report writing and defending/presenting data and concepts to regulatory bodies and licensing authorities, worked in Technology transfer between universities and industries.
Weitere Kenntnisse
Persönliche Daten
- Deutsch (Muttersprache)
- Europäische Union
- Schweiz
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