Project Engineer
SciPro - saint paul, MN
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Project EngineerJob Location: St. Paul, MNDivisionDepartment: EngineeringType of Position: Temporary to possible full-time hire"”"”"”Job SummaryProvide engineering expertise for the support of existing manufacturing operations and improvements of existing medical disposable products. Regular support of manufacturing operations including IQOQPQ activities, risk management documentation, process development and training, LEAN implementation, and other associated activities related to medical products manufacturing.Essential Duties and ResponsibilitiesDefine and implement Verification and Validation activities.Adapt machine or equipment design to factory and production conditions.Facilitate project plans and reviewsFacilitate risk analysis and implements solutions to mitigate identified risks.Will design manufacturing jigs, fixtures and equipmentDevelop manufacturing processes that are applicable to statistical process control, and may develop those techniquesCreate internal label specificationsInspect performance of equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.Support manufacturing, helping to produce products meeting quality standards, cost targets, and production schedules. Provide guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.Support purchasing with complete documentation as required. Source, visit, and qualify vendors.Perform failure analysis, complete corrective actions and preventative actions as needed to support qualityProvides cost and expense information as required to accounting.Other duties as assigned by managerExperience & Education RequirementsBachelor's Degree in Engineering OR equivalent3-5 yrs. medical device experience preferredProgram ManagementSoftware proficiencyMicrosoft Word, Excel, PowerPoint, Project, Solidworks, Minitab.Manufacturing process knowledge including:Lean Manufacturing.Packaging and labeling.Automation selection preferredSterilization processesExperience with small to large semi-automated equipment implementation including:Working with outside equipment manufacturers for quotesDesign inputsValidations (FAT, SAT, IQ, OQ, PQ)Materials selection knowledge including physical properties and biocompatibility (ISO10993)Product Design knowledge design for manufacturing, and drafting standardsFDA and ISO design control regulationsPossess excellent verbal and written communication skills and organizational skills while managing multiple priorities, often under deadlines.**This position is not eligible for a relocation package**Applicants for employment must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (i.e., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant status).EOEDisabledVeteran
Created: 2024-10-21