Since October 2014
With a focus on embedded, machine control and medical systems I build on the strengths of our customers and provide the needed steps to make the product, service or process introduction a success. This includes conceptual design, architectural design, product development, process and services design, proto product realization, engineering and production test environments, volume production and world wide distribution. Working on long term relationships between AllRound Technology and our customers.
March 2012 --- December 2014
Consultant Quality Systems for medical device industry
June 2010 --- September 2014
Own company providing services in: (Medical) quality systems, ISO13485, ISO9001 CE certification of machinery Electronics and software design for medical and industrial applications.
Senior Tooling Engineer EMT
March 2009 --- February 2012
Hardware group leader
July 2008 --- March 2009
August 2002 --- June 2008
R&D and production manager for the design, engineering and production of medical devices according to regulations and customer demands.
January 1998 --- January 2002
As project lead responsible for quoting, designing and implementation of machine control systems for paint dispensers and other production machines.
January 1997 --- January 1998
From a technical background optimized windmill blade production processes by implementing new control software, redesigning ESD protection electronics and training of operators.
FlexibilityOptimismAnalytical thinkingCreative thinkingCuriosityEfficiency
Negotiation Medical devices R&D Scientific writingAnalytical techniquesAutomationBudget ManagementBudget NegotiationBudgetingBudgetsBusiness DevelopmentBusiness IntelligenceBusiness PlanningBusiness Process ImprovementC++Change ManagementClinical trialsCMC Regulatory AffairsCompliance with regulationsContract negotiationCross-functional team leadershipCurrent Good Manufacturing Practice (CGMP)Data AnalysisData ManagementDatabasesDesign of Experiments (DOE) Electrocardiogram (ECG)Electronic Data Capture (EDC) ElectronicsElectrophysiologyEngineeringEnglishEnglishFailure Mode and Effect Analysis (FMEA)ForecastingGood Manufacturing Practice (GMP)Healthcare Information TechnologyHealthcare industryKey Account ManagementLaboratory TechniquesManufacturingMaterials ScienceMedical DevicesMicrosoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft ProjectMicrosoft WordNegotiationNew Business DevelopmentOutlookPre-clinical researchPreclinical SafetyProblem SolvingProblem-solving methods and troubleshootingProcess EngineeringProcess improvementProduct designProduct developmentProduct managementProgram ManagementProgrammingPublic SpeakingQA complianceQC releaseQualificationQuality Assurance (QA)Quality AuditingQuality Control (QC)Quality ManagementQuality Management System (QMS)Quality SystemsRegulatory affairsRecruitingRegulatory ComplianceRegulatory RequirementsRegulatory submissionsReport WritingResearchRisk ManagementRisk AssessmentSalesSix SigmaSoftware DocumentationSQLStart-upsStatistical Data AnalysisStatisticsStrategic PlanningStrategyTeam LeadershipTeam ManagementTime ManagementValue Stream Mapping
Skills and Expertise
Analytical skills Analyze data Guide students Interact with nurses Interact with physicians Technology research Use content management systemsCoachCoordinate regular advisory boardDevelop regulatory strategyDevelop software programsDevelop Quality Risk Management (QRM) initiativesEnsure data integrityEnsure data consistencyIdentify risksImplement ProcessesImplement Quality Management System (QMS)Interact with computer specialistsInteract with nursesInteract with physiciansInteract with pre-clinical scientistsInteract with regulatory stakeholdersInteract with statisticiansInterpret analytical resultsInterpret electrical schematicsLead studiesLead teamsLiaise with doctors and other professionals throughout the studyMaintenance of biomedical equipmentManage budgetsManage multiple projectsManage projects resourcesManage risksManufacture of GMP batchesNegotiationOperate research equipmentProvide input to process improvement initiativesProvide trainingR&DSelect contractors Solve problemsStorytellingTeach university studentsTeachingUnderstand protocolsWrite documentsWritten presentation
Master in Biomedical electronics from University of Twente in 1997
Phd in Medical electronics from Hogeschool Enschede in 1995
Training and Certification
Project management in 2004 Training