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Position Summary The Senior Packaging Engineer is responsible for supporting and driving packaging related projects through adherence to established quality system requirements, design control processes, good engineering, and documentation practices. The key responsibility of this position is to exercise medical device packaging subject matter expertise, sound judgement and take action while adhering to defined procedures during project support & improvements.The Packaging Engineer will complete engineering projects with input and guidance from senior level engineers and managers. Will gain exposure to some of the complex tasks within the job function.Essential Duties & ResponsibilitiesResponsible for the development and analysis of sterile or non-sterile barrier components and assemblies for medical devicesEnsure proposed packaging design changes are systematically and thoroughly analyzed through proper justification and/or data collection for verification of performance requirementsIdentify and implement process and product modifications to improve manufacturability and profitabilityConsult with Manufacturing and Quality Engineers on in-process packaging related non-conformancesSupport project timelines and milestones and bring them to completion on time and within budgetAssist in completion of CAPA tasks and deliverables (Corrective and Preventive) as assignedInitiate and manage projects with adherence to program management guidelinesConducts independent analysis and develops solutions to problemsWrites detailed technical documentationDelivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaborationWork on special projects as they ariseKnowledge, Skills & QualificationsProficient in packaging engineering, structured problem solving, use of statistical tools (proficiency will align with job level)Proficient knowledge of external packaging standards and methods such as ISO 11607-1, ISO 11607-2, ASTM D4169, etc. (proficiency will align with job level)Knowledge of the Medical Device Industry and familiarity with FDA QSR Regulations is a plusCompetent in your domain. Familiar with other areas of domain expertise within the team (competency will align with job level)Has a basic understanding of best practices. Has a good understanding of engineering disciplineHas awareness of the broader product strategy and contribute to itAbility to receive general project direction and solicit input from more experienced engineers.Requires the ability to independently make decisions that impact the attainment of the projectMinimum Qualifications, Education & Experience~ Bachelor of Science degree from an accredited college or university in Packaging Engineering or a related field.~3-8+ years of experience in Medical Device Packaging (experience will align with job level)
