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Packaging Engineer
Ref No.: 18-26657
Location: Plymouth, Minnesota
Start Date / End Date: 05/28/2018 to 05/28/2019
Company: Artech Information Systems
Job Title: Packaging Engineer
Location: Plymouth, MN
Duration: 12+ month’s contract
Job ID: 18-26657
Position Description
  • Responsible for the design, development, and support of package systems and processes for sterile medical devices including components, assemblies, and labels.
Position Responsibilities
  • Accountable 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.
  • Leads the improvement and standardization of packaging on existing products with focus on performance and cost effectiveness.
  • Actively collaborate with Packaging and Labeling peers within CardioVascular to identify and implement best practices, packages and processes.
  • Participate on cross-functional, cross-site project teams focusing on packaging, packaging technology and processes improvements
  • Utilize knowledge of FDA and ISO requirements related to packaging and labeling, ensuring robust package validation and qualification
  • Draft technical documentation including package testing protocols and validation associated with the qualification and release of package designs
  • Process development and support for packaging assemblies for manufacturing
  • Develop plans to establish proof of shelf life, accelerated and real time.
  • Coordinate projects and deadlines working with P&L lead to ensure all new product and package improvement deadlines are met.
  • Execute all aspects of packaging development and testing as required
  • Serve actively in the identification of suppliers, testing and approving materials, including liaison with the vendors.
Basic Qualifications
  • 5 year’s experience with a BS Packaging or related engineering field (e.g. Mechanical or Materials); 3 years with MS
  • Medical device or Pharma packaging experience
  • Knowledgeable in ISO, ASTM, ISTA standards related to packaging.
  • Solid proficiency in MS Word, Excel and statistical analysis software
  • Familiarity with FDA quality assurance requirements for design and manufacturing.
  • Ability to travel up to 15%, both domestic and international.
Preferred Qualifications
  • Certified Packaging Professional (CPP) preferred.
  • Experience with ethylene oxide, steam, liquid chemical, and radiation sterilization methods
  • Experience with Design for Lean Sigma (DFLS), Design for Manufacturability (DFM), process development and design of experiments (DOE) methodology Experience with Design Verification and Process Validation.
  • Experience with sterile barrier sealing equipment and processes
  • Experience with MiniTab, Microsoft Project, Solidworks, MatrixOne, Agile, QAD. and SAP software.
Rajiv Maruthi