Medical device consultancy

12/2018 – offen

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.

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