Senior Packaging Engineer

2 weeks ago

Bloomington, United States Cook Medical Full time

Overview

The Senior Packaging Engineer procures and develops packaging for new and existing products. This individual leads packaging activities with a cross-functional team including SBU Product Management, Regulatory Affairs, Operations, Quality Assurance, Clinical Affairs, and other personnel, including New Product and Sustaining Engineering. Direct interaction with the Global Sterilization group in the review, planning and execution of packaging efforts for current and potential sterilization modalities. Deeply connected and involved in all aspects of the Global Sterilization Corporate Program (GSCP) and in development of global packaging processes.

Responsibilities

• Member of Global Sterilization Corporate Program (GSCP)

• Develop global packaging processes and libraries

• Work directly on global new product development

• Apply packaging design principles from the pharmaceutical/medical device field to maintain and develop appropriate packaging solutions
• Develop and maintain department standards in packaging. Inclusive of environmental and regulatory standards related to medical packaging design and test (., ASTAM F1886, F88, F2096, D4169 and ISO 11607)
• Ability to lead multiple projects to successful completion with tight timelines and critical deliverables
• Ensure compliance of equipment and packaging designs with company quality system
• Perform verification and validation testing of packaging designs and manufacturing methods
• Write and maintain appropriate documentation per the company quality system
• Evaluate issues with existing packaging and implement corrective actions

• Work with appropriate suppliers to implement packaging and package handling systems, including material and equipment selection, for new and existing products

• Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals
• Must strictly adhere to safety requirements
• Maintain regular and punctual attendance
• Must maintain company quality and quantity standards
• Must have effective oral and written communications throughout various levels of the global organization
• Ability to work in collaborative and independent work situations and environments with minimal supervision
• Ability to remain calm and receptive in fast paced situations

Qualifications

• Master of Science in Packaging Science, or closely related field and 3 years experience; or Bachelor's degree in Mechanical Engineering, Packaging Science or closely related field and 5 years experience; or experience of such kind and amount as to provide a comparable background

• Product and packaging stability and/or accelerated aging testing a plus

• Experience with medical packaging materials (Tyvek, PE/PET films, PETG trays,

• Experience with environmental and regulatory requirements and standards that relate to medical packaging design and testing (. ASTM F1886, F88, F2096, D4169, and ISO 11607)

• A problem-solving approach with application of root cause analysis and failure mode methodology

• Ability to work with, interpret and apply packaging engineering drawings and specifications. Solid modeling design a plus

• Experience in developing and applying and fulfilling design inputs requirements for packaging

Physical Requirements:

• Works under general office environmental conditions

• Works with manufacturing teams on continuous improvement processes in the manufacturing environments

• Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.

• Research and designs using standard computer equipment

• The employee is frequently required to stand; walk; use hands to grasp, feel or touch; reach with hands and arms; climb or balance; stoop; kneel; crouch; or crawl; and talk; or hear

• Moderate exposure to noise level in the work environment that is moderate to occasionally loud
• Occasionally lifts and/or moves up to 55 pounds

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