Packaging Engineer

Job Description

Job Title: Packaging Engineer with Sold works tool experience 

GENERAL FUNCTION & RESPONSIBILITIES: 

• Good knowledge in ISO Part one and Part two. 
• Responsible for development of packaging processes that are standardized across multiple facilities globally. 
• Working experience in cost improvement projects in sustaining engineering
• Provide the lead technical role in managing the design, development, testing, and validation of packages and packaging systems for medical devices. 
• Develop sterile barrier pouch designs, detailed specification and tolerances, material selection, supplier selection, label designs, secondary packaging configurations, test methods, and IQ/OQ/PQ protocols and reports. 
• Provide the lead technical interface with material suppliers, test labs, outside contractors, and the Quality, Engineering, and R&D teams for all packaging related issues. 
• Demonstrate a commitment in understanding medical device manufacturing, ISO, FDA regulations through active participation in company training as well as through self-education by reading related articles and attending seminars. 
• Understand and comply with GMP, FDA, and ISO requirements. 
• Establish timelines, budget estimates, and resource requirements for package development projects and drive the projects to successful completion. 
• Plan, organize, and schedule efficiently; effectively manage multiple projects, establish contingencies, deliver on promises, and complete the required documentation. 
• Work efficiently on computer using Microsoft Office and Minitab statistical software for creating DV protocols, DV Report, gathering data, performing statistical analysis, and generating reports. 
• Perform gap assessment on DHF files with respect to various packaging standards. 
• Create 3D CAD packaging model using Solid works for further analysis and representation.   
• Aware of PLM tool - SAP 
• Knowledge on ASTM, ISTA, TAPPI testing standards.  

QUALIFICATION 

• Bachelor / Master’s degree in Packaging Technology or a related discipline. 
• 2 to 3 years of experience

Tools Expertise:

• Solid works, Auto CAD, ArtiosCAD, Minitab, TOPS

EXPERIENCE 

• Rich experience in packaging developing/optimization and validating sterile pouches for medical devices. 
• Knowledge in all design control activities and cost improvement project in sustaining engineering
• Experience developing and executing IQ/OQ/PQ protocols and reports, preferably for sterile barrier medical device packages. 
• Demonstrated knowledge of regulatory requirements such as ISO, GMP, FDA, CAPA and others. 
• Intermediate knowledge related to paperboard, corrugated, flexible packaging films, Tyvek, thermoformed trays, injection molded parts, and packaging equipment. 
• Working experience in Solid works.