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Must have FDA regulatory experience; LOCAL CANDIDATES PLEASE OR WILLING TO RELOCATE IMMEDIATELY; Packaging engineer field of study or experience in packaging engineering - 2 - 3 years of experience
Job Responsibility:
Validation and testing of commercial package design and any modifications to existing package design
Recommends appropriate packaging equipment, tooling, and/or materials to meet regulatory requirement for package testing
Converts customer/regulatory needs into existing package design
Develops prototypes of concepts and subcomponent mechanisms
Designs/re-designs and develops tooling and fixturing required to support existing or package design/re-design
Utilizes design concepts and analysis techniques
Works with vendors and customers to identify appropriate materials and components to meet packaging requirements
Analyzes existing design to ensure that the specifications (Product Performance Specifications) meet the customers’ and/or regulatory requirement
Ability to detail re-designs to ensure manufacturability
proper dimensioning and tolerances stack-up analysis. Recommends modifications as required
Establishes and maintains appropriate documentation of activities in accordance with existing policies and procedures (Divisions, Corporate, and Regulatory compliance)
Actively participates on MDR project team meetings and/or Design Reviews
Requirements:
FDA regulatory experience
Packaging engineer field of study or experience in packaging engineering - 2 - 3 years of experience
Proven ability to design/re-design existing commercial packaging
Proficient in the use of a personal computer with intermediate keyboarding skills and proficiency in the use of Microsoft Word, Excel, PowerPoint, Access, Microsoft Project, and various statistical software packages
BS in Packaging Engineering or related field of study
Minimum 2 years experience or relevant experience
Regulated industry experience a plus
Microsoft Word, Excel, Project, PowerPoint and Access