freiberufler Medical device consultancy auf freelance.de

Medical device consultancy

offline
  • 100€/Stunde
  • 6211LN maastricht
  • Europa
  • nl  |  en  |  de
  • 22.04.2023

Kurzvorstellung

Expert in Medical devices, technology outsourcing, technology transfer, project management, R&D

Qualifikationen

  • Chemie
  • Creative direction
  • Mikrotechnik / Mikrostrukturtechnik
  • Nanoelektronik
  • Outsourcing
  • Produktdesign
  • Projektmanagement
  • Technische Projektleitung / Teamleitung

Projekt‐ & Berufserfahrung

see CV below
see CV below, Aachen
12/2018 – offen (5 Jahre, 4 Monate)
Life Sciences
Tätigkeitszeitraum

12/2018 – offen

Tätigkeitsbeschreibung

found in reference description 0
Dr [...] WA [...]

Residence Maastricht, The Netherlands
Nationality Dutch
Date of birth 09.05.1957

CV
Company
Fuction
Period
Key
Successes
Desciption
Company
Function
Period
Key
Successes

Description



Company [...], Madrd, ES
Consultancy
Octorber 2018
Technology scaling options assesment

Options to scale production volume from R&D to Manufacturing
[...] group, Basel, CH
Consultant Quality
April 2018 – August 2018

• MDD to MDR gap analysis

• Assessment of quality of documentation
• Definition of remediation activity


[...], Madrid, ES
Function Consultant Strategy
Period November 2017 – December 2017
Key Successes • Advice on reallocation of micromechanical development activity
Description • Auditing potential partners
Company [...], Rheinfelden, DE
Function Development Lead
Period June 2017 – October 2017
Key Successes • Initialise development of a lead
• DHF activities for a medical implant project @[...]
Description
• Manage the initial development of a lead in close collaboration with the customer
• Customer contacts, progress reporting (weekly telco, site visits)
• Budget and planning
• Definition of the BOM
• Compiling Feasibility reporting, PFMEA and other DHF issues
• Compiling test and verification protocols
• ISO 13485, implant norms and standards (including sterile packaging)

.
Company [...], Eindhoven, NL
Function Senior Principal engineer micromechanics
Outsourced development manager

Period September 2015 – May 2017
Key Successes • Technology transfer from Europe to USA
• Design for manufacuring and cost saving
• Test and verification tool development
Description • Partner selection and auditing (USA)
• Chair weekly progress meetings with partners (suppliers)
• Chair design review meetings
• Chair Audit and progress meetings
• Budget and timeline responsibility
• Maturing DHF files (from paper based to electronic)
• Write SDS, PFMEA documents
• Developem validation and verification protocols
• Mechanical drawing sigh-off
Company [...], Eindhoven, NL
Function Principal engineer micromechanics
Period May 2012 – April 2015
Key Successes • Class III medical implant development
• Successful maturing start-up toward acquisition by Medtronic
Description • Micromechanical engineering of brain lead
• Technology outsourcing
• Management partners development/production in France, UK, USA, Switzerland
• Budget and timeline planning
• Analysis of surgical procedure and design review (human factor)
• DHF and V model, comprising: System requirements Specs (SRS), DFMEA
• Supplier quality audits
• CE and FDA requirements
• Team building (grow from 7 FTE towards 70 FTE)
• BOM selection (metals, ceramics, polymers and coatings (parylene))
Company [...], Eindhoven, NL
Function Senior Scientist
Period January 2008 - June 2012
Key Successes


Description • Realisation of a Vacuum Roll2Roll barrier foil CVD/printing tool.
• Coaching [...] scientists
• EU proposal (9 mlj euro) granted
• EU programme management
• OLED lighting and display technology program development
• Processing on foil technology program development
Company [...] (Eindhoven (NL), Leuven (BE), Aachen (GE), Santa Barbara, Austin (USA))
Function Principal Scientist / Senior Assignee
Period 1986-2008

Semiconductor, Display, OLED, Lighting, Optoelectronics, Passive Components


Education/ Certificates
Education
1986 PhD Chemistry
University Utrecht, NL


Skill List/Professional Knowledge
Key Skills

• Ability to motivate a team.
• Broad technical background
• International expertise (East and West)
• Multicultural management
• Effective communicator with excellent problem solving and organization skills in project conflict resolution.

Eingesetzte Qualifikationen

Produktdesign

Ausbildung

University
Ausbildung
1976
Utrecht

Über mich

medical device expert consultant
Realise the impossible

Weitere Kenntnisse

Chemist by training,

Persönliche Daten

Sprache
  • Niederländisch (Muttersprache)
  • Deutsch (Gut)
  • Englisch (Fließend)
  • Französisch (Grundkenntnisse)
Reisebereitschaft
Europa
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Profilaufrufe
2269
Alter
66
Berufserfahrung
42 Jahre und 1 Monat (seit 02/1982)
Projektleitung
9 Jahre

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