Packaging Engineer II

Benefits

Additional Information

Why Orthofix? Guided by our organizational values - Take Ownership | Innovate Boldly | Win Together - we collaborate closely with world-class surgeons and other partners to improve people's quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the unrivaled partner in Med Tech. Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people's lives? Look no further. How you'll make a difference? As a Packaging Engineer II on our Packaging team, you'll be responsible for designing, testing and validating packaging systems for our spinal implants, Biologics, and surgical instruments. This includes creating and documenting requirements of new packaging development including prototyping, verification/validation testing, design for manufacture, and transfer to manufacturing within a design control environment. You will help support packaging recommendations based on experience for a variety of implant (or instrument) projects and help support packaging strategies and timelines associated with individual projects. This is a highly collaborative role and you'll partner with Product Development Engineers, Marketing, Quality, Manufacturing, Operations, and 3rd party vendors/suppliers. What will your duties and responsibilities be? The following are the essential functions of this position. This position may be responsible for performing additional duties and tasks as needed and assigned. Work within a project team to gather user needs and design inputs, then be responsible for the design of new packaging systems and related packaging process steps and processing equipment for a variety of spinal implants, Biologics, and surgical instruments Create and launch design and development plans, verification and validation plans for packaging related projects within a design control environment Work with vendors and Operations team on technical issues while supervising packaging designs throughout the manufacturing process. Significant involvement in packaging system and process transfer to Manufacturing/Operations and on-going support after commercialization Effectively interact with cross-functional teams within Marketing, Purchasing, Quality, Manufacturing, and Operations to drive project plans and achieve project objectives Support investigations relating to packaging issues, product release performance, and/or customer issues Partner with Quality and Regulatory Affairs colleagues to ensure compliance with regulatory authority guidance for sterile operations Create standard operations procedures, standard test procedures, and other related records Identify and lead cost reduction opportunities What skills and experience will you need? The requirements listed below are representative of the education, knowledge, skill and/or ability required for this position. Education/Certifications : Bachelor's degree in Packaging Engineering Experience, Skills, Knowledge and/or Abilities : 2 - 5 years packaging experience in a Class II medical device environment Experience performing and/or supporting packaging equipment and utility qualifications and validations Understanding of packaging engineering fundamentals and technical knowledge of packaging materials, equipment, and supporting utilities Demonstrated success in creating and maintaining design control documentation Experience with medical device packaging/labeling equipment design/validation and manufacturing process development Knowledge of ASTM package testing methodologies and test standards, and risk management and processes Knowledge and understanding of FDA regulated environment, package protocols, GMP, and ISO requirements Ability to effectively communicate verbally and through written correspondence with all levels of peers and leadership within the Company, surgeons, suppliers, etc. Proficiency with MS Office, specifically Excel and PPT Ability to work creatively, prioritize, and accomplish team goals and initiatives amidst competing priorities Analytical mindset with strong attention to detail, and ability to problem solve and identify solutions in a high-growth and fast-pace environment What qualifications are preferred? The education, knowledge, skills and/or abilities listed below are preferred qualifications in addition to the minimum qualifications stated above. Education/Certifications : No additional requirements Additional Experience, Skills, Knowledge and/or Abilities : Experience in medical device ERP experience CAD drafting and modeling, using Pro-E, Creo, SolidWorks, or similar Familiarity with ASTM D4169, ISO 11607, and ISO 11137 PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS The physical requiremen