Pilot Principal Quality Engineer Digital Strategy Manager
Irvine, CA, US
November 2022 - present
company
Edwards Lifesciences
title
Pilot Principal Quality Engineer Digital Strategy Manager
overview
- Leading the process qualification activities for the flagship Commander M EU DS, ensuring adherence to industry standards and regulatory requirements
- Developing comprehensive rapid launch framework to ensure quality continuous improvements during transfers are communicated and improved upon
- Created the first Digital Strategy Roadmap for Irvine Pilot, supporting Smart Supply Chain (SSC) initiatives, filling the gap in structured digital strategy
- Rapidly built strong relationships with corporate leaders in IT, Digital Transformation, Digital Innovation Labs, Product Data Governance, and other key organizations
- Anticipated foundational needs and identified over a dozen digital projects with Subject Matter Experts (SMEs), supporting MRP Maturity, Optimized & Simplified Receiving Inspection, Digital Performance Management, and Rapid Launch & Transfer initiatives
- Chartered a Site Project for 2023, on track for approximately $200k in cost reduction/avoidance, with an additional $380k projected for 2024
- Directed 2023 digital Pilot projects with 19 cross-functional resources, both internal and external to Pilot
- Partnered with SMEs and Business System Analysts to co-lead projects, utilizing influence management skills to drive elimination of non-value-added work and challenge the status quo
E
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Skills
Adobe InDesignAlgorithm DesignAlgorithmsApplied ScienceAutomationBiologyBusiness Process ImprovementBusiness SystemsCertified Supply Chain ProfessionalChemical EngineeringClinical WorksCoagulationCommunication SkillsConfiguration ManagementConsultingContinuous Quality ImprovementCost ReductionCycle Time VariationData AnalysisData GovernanceDigital StrategyDigitizationEngineering EducationFailure Mode Effects AnalysisFluid PipesForecasting SkillsFundraisingGage R&RHealth CareInnovationKnowledge of EngineeringKnowledge of MathematicsKnowledge of PatentsLeadershipLean ProcessesMachine LearningManufacturingManufacturing ProcessesMaster of Business Administration (MBA)Measurement and MetrologyMedical MaterialsMedical RecordsMembranesMetricsMicrofluidicsModel ValidationPerformance ManagementPiping ValvesPower BIPredictive Data AnalysisPredictive ModellingProcess DesignProcurement ManagementProduct and Manufacturing InformationProduct DesignProduct Information ManagementProject ManagementPublic RelationsPumpsQuality ManagementRegulatory RequirementsReliabilityResearch and DevelopmentResearch SkillsRisk ManagementSafety PrinciplesSiliconeSimple Object Access Protocol (SOAP)Single-Minute Exchange of Die (SMED)Six Sigma Green Belt CertificationSix Sigma MethodologyStakeholder ManagementStrategic ManagementStrategic ThinkingSuccess Driven PersonSupplier DevelopmentSupplier Quality AssuranceSupply Chain ManagementSustainabilitySystems AnalysisTeam ManagementTesting SkillsTest MethodsTraining Activities