Ron van Oudenallen

Manager of Operations at FastFocus
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Contact Information
us****@****om
(386) 825-5501
Location
NL
Languages
  • English Full professional proficiency
  • German Professional working proficiency
  • Dutch Native or bilingual proficiency
Skills

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Credentials

  • ISO 27001
    CRANIUM
    Mar, 2022
    - Nov, 2024
  • Security Awareness
    Awaretrain
    Jan, 2020
    - Nov, 2024
  • Supplier Audits
    Udo Consultancy
    Jan, 2018
    - Nov, 2024
  • AgilePM Foundation
    Vijfhart IT-Opleidingen
    Dec, 2017
    - Nov, 2024
  • AgilePM Practitioner
    Vijfhart IT-Opleidingen
    Dec, 2017
    - Nov, 2024
  • Medical Device Software
    MDProject
    Nov, 2017
    - Nov, 2024
  • C Programming
    Vijfhart IT-Opleidingen
    Oct, 2016
    - Nov, 2024
  • C Programming Advanced
    Vijfhart IT-Opleidingen
    Oct, 2016
    - Nov, 2024
  • C/C++ Embedded Development
    Vijfhart IT-Opleidingen
    Oct, 2016
    - Nov, 2024
  • ISO 14974: Risk Management for Medical Devices
    MDProject
    Jan, 2010
    - Nov, 2024
  • VCA-VOL
    NIBHV
    Oct, 2008
    - Nov, 2024

Experience

  • FastFocus B.V.
    • Netherlands
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Manager of Operations
      • Dec 2018 - Present

      Life cycle management of patient monitoring systems Responsible for: • Managing and coaching the operational team, • Managing engineering and manufacturing contractors, • Managing ISO 13485 certification, • Managing CE certification, • Risk management, • Approval of records, • Managing intellectual property, • Realization of the technical road-map. Life cycle management of patient monitoring systems Responsible for: • Managing and coaching the operational team, • Managing engineering and manufacturing contractors, • Managing ISO 13485 certification, • Managing CE certification, • Risk management, • Approval of records, • Managing intellectual property, • Realization of the technical road-map.

  • The Surgical Company PTM
    • Netherlands
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Manager Manufacturing and R&D
      • Jan 2015 - Nov 2018

      Member of the management teamResponsible for:• Performance of R&D department,• Design and development procedures,• Optimization of manufacturing processes,Key achievements:• Realization of a manufacturing line for disposable forced air blankets on time and within budget,• Quality improvement intravenous fluid disposables,• Efficiency improvement automated disposable manufacturing,• Realization innovative material for automated blanket manufacturing,• CE-certification Fluid Compact warming system (Class I disposable device and Class IIb warming device),• Realization of supply chain map and implementation of quality improvement measures. Tasks:• Coaching of R&D engineers and project managers,• Consulting on CE-certification and 510(k) clearance,• Assessment of business opportunities,• Training of distributors and biomedical engineers, • Approval of technical product documentation,• Assessment of subcontractors,• Participate in meetings with key opinion leaders (KOL),• Participate in management team meetings,• Managing intellectual property,• Keeping track of publications on patient temperature management,• Consulting the board of directors on mergers, acquisitions, and new businesses.

    • R&D Engineer / Project manager
      • Jan 2010 - Dec 2014

      • Developed a forced air warming system and disposables,• Developed a blood-and-fluid warming system,• Assessed of patient temperature management in several hospitals • Developed test equipment for fluid warmers, • Developed a model to simulate the effect of temperature management products on patients.

  • Danieli Corus
    • Netherlands
    • Industrial Machinery Manufacturing
    • 200 - 300 Employee
    • Technologist, Project Engineer/Manager, Consultant Ironmaking
      • 2005 - Dec 2009

      • Project management/engineering brownfield and greenfield steel plants, • Operational assistance and site supervision at several plants worldwide, • Developed an alternative iron making process (ULCOS), • Developed a coal pyrolyzer, • Several feasibility studies on plant optimization (efficiency), • Failure assessments, • Studied the thermo-mechanical behavior of blast furnace components (coolers, refractory), • Researched wear mechanisms furnace wall, • Researched flow behavior hot blast, • Mentored junior engineers.

  • Basic Ingenieursbureau
    • Eindhoven, Netherlands
    • Project Leader / Design Engineer
      • 2000 - 2005

      • Managed Basic Ingenieursbureau office in Utrecht • Member of the management team • Performed a conceptual study on a foup door opener (ASMi) • Managed Basic Ingenieursbureau office in Utrecht • Member of the management team • Performed a conceptual study on a foup door opener (ASMi)

  • ASML
    • Netherlands
    • Semiconductor Manufacturing
    • 700 & Above Employee
    • Lead Design Engineer (via Basic Ingenieursbureau)
      • 2000 - 2005

      • Optimized cost of goods of an optical module, • Designed a new machine outer covering, • Designed a lift and rotation module for assembly of a metro-frame of a waferstepper, • Designed a stiff positioning frame for an optical module, • Created a conceptual design of a deep ultraviolet reticle handler, • Created the layout of a new type of wafer stepper, • Researched technical malfunctions in several machines, • Designed manufacturing tools, • Designed stepper seismic anchorage.

  • Neitraco Engineering B.V.
    • Netherlands
    • Industrial Automation
    • 1 - 100 Employee
    • Project Engineer - Mechanical Engineer
      • 1998 - 2000

      • Design of laminate, weld and manufacturing jigs for the aerospace industry, • Design of manufacturing jigs for the automotive industry, • Design of retraction tool for sensors operating in an extreme high pressure environment, • Design of cleaning station for rollers and roller bearings. • Control of manufacturing and assembly, • Set-up of CAD / CAM network, direct coupling Catia / MasterCAM with machining centre, • System management UNIX network, • Supervision of trainees,

Education

  • Open Universiteit
    MSc, Engineering Product Design
    2000 - 2005
  • Hogeschool van Utrecht
    BEng, Mechanical Engineering
    1994 - 1998
  • Versvelt MTS
    AD, Mechanical Engineering
    1991 - 1994

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