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Packaging Engineer - Medical Device II
Ref No.: 19-08834
Location: Alpharetta, Georgia
Our client, a leading medical device company is looking for a Packaging Engineer - Medical Device II. This is for an initial duration of 9 months and is located in Alpharetta, GA
Description/Comment:
  • Performs professional engineering work in the conception, specification, design, manufacture and/or testing of packaging materials and products to contain, protect and ship contents that meet the requirements of FDA/ISO Quality Systems regulations for design and development of medical devices.
  • Intermediate position that requires a Bachelors degree or 2-5 years of equivalent experience.
Hours: 8:00am to 5:00pm


Additional Job Details:
  • The primary purpose for this role is to lead package engineering initiatives for all product categories within Client.
  • Projects include supporting business growth, innovation, quality, and cost savings to achieve Client Health's strategic objectives.
  • The position is expected to influence and drive results with Client internal cross functional groups, global manufacturing sites, and primary vendors.
  • Job Position Scope (Optional) This role typically reports to the Associate Director – Capital, Engineering & Packaging.
  • Incumbent develops and designs packaging structures and materials for safe shipping, handling and presentation of medical products under varying conditions of climate, environment, and different modes of transportation.
  • Demonstrates core packaging principles, applies a broad knowledge of packaging applications in industry and makes packaging technology connections across business platforms.
  • Leads packaging projects of moderate size and complexity with internal and external partners or performs as a packaging resource on cross functional projects of considerable complexity.
  • Provide technical guidance and coaching to less experienced team members.
Job Position Accountabilities / Expectations
  • Carry out all work ensuring effective Safety and Quality attitudes and practices.
  • Design and execute medical packaging for sterile and non-sterile products to support company growth objectives.
  • Develop and implement packaging cost savings initiatives through source reduction, transportation efficiency improvements and the utilization of new packaging technologies.
  • Provide packaging support with acquisitions including package validation due-diligence, re-branding and supplier consolidation.
  • Lead packaging portion of global manufacturing footprint improvement projects.
  • Participate in global packaging vendor selection and qualification by providing professional judgment in the areas of technical competence, process capability, process control, and quality management.
  • Develop and execute packaging validation protocols in compliance with EU Medical Device Directive, FDA, IEC 60601 for Electronic Medical Devices and other global regulatory requirements including IQ/OQ/PQ activities, simulated distribution and handling testing, sterility and shelf life validation.
  • Strong ability to navigate key quality processes such as Change Control and CAPA
  • Develop, implement, and maintain packaging specifications, material specifications, label specifications and packaging bill of materials.
  • Develop / assess intellectual property including invention disclosures, patent searches, right to practice, and patent filings in support of new package structural designs.
  • Responsible for defining budget requirements for specific projects, equipment, etc., and monitors costs for assigned projects.
  • Leverage standard practices to minimize waste and enable continuous improvement to drive improved business results, e.g., visual management and value stream mapping.
  • Bachelor's Degree in Packaging Science or other engineering discipline with package design experience.
  • Working knowledge of ISO, ASTM, ISTA packaging standards.
Qualified candidates please send your word format updated resume at the earliest to sangeeth.k@sunrisesys.com.  Thank You.