freiberufler Professional experience -medical device industry R&D and Regulatory ISO 13485 auf freelance.de

Professional experience -medical device industry R&D and Regulatory ISO 13485

offline
  • 25€/Stunde
  • 67346 Speyer
  • Weltweit
  • de
  • 18.11.2021

Kurzvorstellung

Experienced material scientist /polymer technology/Expert -medical devices R&D /regulatory medical devices (ISO 13485)

Qualifikationen

  • Biomaterials
  • FMEA (Failure Mode and Effects Analysis)8 J.
  • Forschung & Entwicklung19 J.
  • Madical devices
  • Materialwissenschaft und Werkstofftechnik2 J.
  • Regulatory Affairs8 J.
  • Technischer Support17 J.
  • Technisches Testing8 J.

Projekt‐ & Berufserfahrung

Head R&D /Forschung entwicklung/Regulatory documentation ISO 13485
Dynamic Technomedicals Pvt ltd, Kochi
8/2016 – offen (8 Jahre, 4 Monate)
Gesundheitswesen
Tätigkeitszeitraum

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

Eingesetzte Qualifikationen

FMEA (Failure Mode and Effects Analysis), Forschung & Entwicklung, Regulatory Affairs, Technischer Support, Technisches Testing

University of Portsmouth accredited Lecturer, Systems engineering Department
Military Technology college, Oman/ Univers, Muscat
7/2014 – 8/2015 (1 Jahr, 2 Monate)
Hochschulen und Forschungseinrichtungen
Tätigkeitszeitraum

7/2014 – 8/2015

Tätigkeitsbeschreibung

teaching systems engineering (Materials and Hardware ) to engineering students and conducting practicals.

Eingesetzte Qualifikationen

Lehrprogramme

Polymer scientist
Waterford Institute of Technology, Ireland, Waterford
12/2013 – 7/2014 (8 Monate)
Hochschulen und Forschungseinrichtungen
Tätigkeitszeitraum

12/2013 – 7/2014

Tätigkeitsbeschreibung

Industrial projects trouble shooting, formulation issues resolving, testing and characterization- report to industry

Eingesetzte Qualifikationen

Projekt - Berichtswesen, Technischer Support, Werkstoffprüfung

Product Application Manager/Research assistant/Chemical Analyst (Festanstellung)
Bio Gate AG, Nuremberg
1/2005 – 5/2013 (8 Jahre, 5 Monate)
Gesundheitswesen
Tätigkeitszeitraum

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

Eingesetzte Qualifikationen

Analytische Chemie, Forschung & Entwicklung, Prüftechnik (allg.), Technische Dokumentation, Technischer Support

Project leader _EU project (Festanstellung)
Inst for materials science, Institute for polymer, Erlangen
3/2002 – 12/2004 (2 Jahre, 10 Monate)
Hochschulen und Forschungseinrichtungen
Tätigkeitszeitraum

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)

Eingesetzte Qualifikationen

Analytische Chemie, Forschung & Entwicklung, Projektleitung / Teamleitung (IT), Materialwissenschaft und Werkstofftechnik, Werkstoffprüfung

Wissenschaftlische Mitarbeiter (Festanstellung)
Leibniz Institute fur Verbundwerkstoffe GmbH, (IVW, Kaiserslautern
1/2001 – 12/2001 (1 Jahr)
Hochschulen und Forschungseinrichtungen
Tätigkeitszeitraum

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.

Eingesetzte Qualifikationen

Kunststoffverfahrenstechnik, Naturwissenschaft, Recycling / Abfallverwertung

Zertifikate

Lean Six Sigma (green belt)
2019
PhD
1999

Ausbildung

PhD
Polymer Engineering
2000
Erlangen, Eermany

Über mich

Many years of experience in Medical devices industry in reseach and development and in the regulatory documentation support, ISo 13485 , ISo 10993, ISO 14971, ISo 14155, ISo 68366 , ISO 11135, polymer formulation development, rubber technology, thermoplastic elastomers development testing.
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

Post doc, MBA , PhD in Polymer technology, MS in Analytical Chemistry

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
Reisebereitschaft
Weltweit
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Profilaufrufe
379
Alter
54
Berufserfahrung
19 Jahre und 10 Monate (seit 01/2005)
Projektleitung
12 Jahre

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