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Packaging Engineer - Medical Device

LanceSoft INC
Santa Rosa, California, United States
June 15, 2018

Position Description

• Responsible for the design, development, and support of package systems for sterile medical devices including components, assemblies, and labels.

Position Responsibilities

• Responsible for the development and implementation of packaging for existing and new medical products and devices including class-II and class-III implantable products, drug/device combination products, and accessories.

• Coordinate introduction / implement changes in packaging, process and materials.

• Provide input on packaging considerations to the device design and development process.

• Work closely with R&D and manufacturing to implement packaging changes. Prioritize and manage multiple projects, leveraging resources to meet project milestones and timelines.

• Responsible for evaluation of materials, design, and configuration of primary, secondary, and other packaging to optimize customer benefit, operations requirements, and the supply chain requirements.

• Consider shipping, warehousing, and supply chain requirements for packaging, recommend improvements and implement the most efficient packaging solutions, considering cost, waste, damage, customer needs, etc.

• Draft technical documentation including package testing protocols and validation associated with the qualification and release of package designs

• Perform other related activities and special projects as needed.

Basic Qualifications

• 2-4 years experience with a BS Packaging or related engineering field (e.g. Mechanical or Materials); 0-2 years with MS

• Must be proficient in the use of computers and PC based programs such as Word, Excel, Project, Powerpoint.

• Experience working in a cross-functional team environment.

Preferred Qualifications

• IoPP Certified Packaging Professional (CPP) certification.

• Knowledgeable in ISO, ASTM, ISTA standards related to packaging.

• Experience with automated packaging equipment and lines.

• Experience with Solidworks, Agile, and SAP software.

• Experience with process development and design of experiment (DOE) methodology.

• Familiarity with FDA quality assurance requirements for design and manufacturing.