Senior Packaging Engineer
restor3d - wilmington, NC
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Job Summary The Packaging Engineer will be responsible for assisting with the design, selection, development, qualification, support and scale-up of production processes and equipment across different manufacturing departments.This position develops new packaging as needed, assesses and resolves packaging problems, and works with vendors as needed. Duties and responsibilitiesDevelop and maintain strong, internal working relationships across both North and South restor3d facilitiesUnderstand the objectives, responsibilities, and mission of the Engineering department and work towards those goalsPrioritize and plan work activities; adapt for changing conditionsInitiation, execution, and documentation of IQ, OQ, & PQ activitiesOptimization of manufacturing processes (5S) for Lean ManufacturingDay-to-day Cleanroom packaging production support activities such as NCMRs and CAPAsProcessing of documentation change requests from originator to final approvalWriting and executing process validation plans and reports, using sound, data- & stats-supported resultsUsing Statistical tools for alternative material evaluations and validations projectsSupport of material handling and control systemHelp conduct time studies and process flow mappingAssure compliance with the requirements set forth by US FDA QSR and ISO regulationsInterpret standards and FDA requirements for device packaging and validationsApply sterilization requirementsstandards to packaging design and validationWork cooperatively with process development, quality, manufacturing, regulatory, and marketing to ensure project successDocumentation of manufacturing packaging processes and inspection criteria within the company's documentation proceduresEvaluate and recommend capital packaging equipment to best suit the needs of the company's selected fabrication processesParticipation on project teams as a contributor bringing proactive solutions and executionOther responsibilities as assigned Qualifications and experience Required Skills: Excellent written and verbal communication skillsAble to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detailDemonstrated ability to monitor own work to ensure quality, accuracy, and thoroughnessStrong organizational, analytical, and time-management skillsAble to self-motivate and work both independently and as part of a teamUnderstanding of ISO 13485 and QSR regulationsKnowledge of statistical analysisKnowledge of computer added design (SolidWorks preferred)Ability to work independently as well as on teams to perform root cause analysis and provide solutions to the root cause.Education and Experience:Bachelor's Degree in Packaging Engineering5-7 years previous experience in an FDA regulated industry required: medical device, pharmaceuticals, biotech, andor life sciences; orthopedics experience preferred.Experience in EO and VHP Sterilization modalitiesExperience working ISO Class Cleanrooms or Controlled EnvironmentsPrior experience documenting manufacturing processes and creating Work Instructions and Standard Operating Procedures for a high-volume production floorPrior experience in just-in-time manufacturing or prototype development preferredWorking knowledge of MS Word, Project, PowerPoint, and Excel, AutoCAD or SolidWorks preferredPreferred education and experience:Master of Engineering Degree strongly preferredPhysical Requirements: Prolonged periods sitting at a desk and working on a computer
Created: 2024-09-30