Duration:0-9 month(s)
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.
Additional Job Details:The primary purpose for this role is to lead package engineering initiatives for all product categories within Halyard. Projects include supporting business growth, innovation, quality, and cost savings to achieve Halyard Health’s strategic objectives. The position is expected to influence and drive results with Halyard 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. •
Last updated on Jul 29, 2019