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Advanced Manufacturing Engineer I

Company: BD
Location: warwick
Posted on: May 3, 2021

Job Description:

Job Description SummaryThe Advanced Manufacturing Engineer I (AMEI) will be primarily responsible for detailed project management, engineering support and direction for manufacturing activities to support the development and commercialization of new products. In addition, this role may support sustaining engineering activities including capacity expansions and failure analysis on existing platform based products.Job DescriptionSupport new product team design activities including:Provide concept developmentinputDevelop project plans and schedulesLeading process reviews and assessing design for manufacturabilityPlan, coordinate and manage all manufacturing activities associated with commercialization and launch of new products including:Concept and development of all methods and processesCoordination of all development and manufacturing of new tooling and equipmentCoordination and support of all new vendor toolingDevelopment and release of all product and process documentation including Process Specifications, Process Controls and PFMEAsPerforming process characterization of all new operations and processes using design of experiments (DOE)Developing, executing, analyzing and writing reports for validation protocolsPreparation of capital equipment requisitionsPlan, coordinate and manage all activities to transfer new products from design to manufacturing including:Development and management of a transition plan and teamProcess documentation transfer and reviewFacility selection, coordination & preparationEquipment moves and installationIQ, OQ, PQ protocol development and execution supportProduction startup and training supportSupport sustaining manufacturing projects including:Leading / supporting failure investigationsProject planning and execution of small to medium scale projectsProtocol generation (characterization through validation) and executionChange implementation planning (including coordinating quality and regulatory timing with cross functional team)Qualifications, Knowledge and Skills RequiredBS degree in Engineering required (mechanical, chemical, biomedical or equivalent)AME I - BS degree with minimum 3 years experience or MS degree with minimum 2 years experienceDemonstrated proficiency in equipment and tooling procurement and chemical process designHigh level of written and verbal communication skillsAbility to conceptualize ideas, motivate and focus individuals and teams and drive projects through completion on time and on budgetUnderstanding and ability to execute DOEs, process validations and process characterizationsWorking Knowledge of Six Sigma methodologies. Six Sigma Green / Black belt certification preferred.Project management experience preferredUnderstanding of GMPs and medical device regulations as they apply to manufacturingAbility to travel up to 25%Primary Work LocationUSA RI - WarwickAdditional LocationsWork Shift

Keywords: BD, Warwick , Advanced Manufacturing Engineer I, Other , warwick, Rhode Island

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