The packaging engineer will design and develop novel packaging solutions for new product development and sustaining engineering projects for the Restorative Therapies Group. The role will also participate and lead cross functional teams consisting of R&D, Operations, Regulatory, Quality, Supply Chain and Labeling to ensure robust packaging development and engineering support across various manufacturing sites.
Day In The Life-
- Responsible for the design, development, and support of package systems and processes for sterile & non-sterile medical devices including components, assemblies, and labels.
- Supports the improvement and standardization of packaging on existing products with focus on compliance, performance and cost effectiveness.
- Collaborate with Packaging and Labeling peers 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.
- Support and execute all aspects of packaging development and testing as required
- Actively participate in the identification of suppliers, testing and approving materials, including liaison with the vendors.
- 2+ years experience with a BS Packaging or related engineering field (e.g. Mechanical or Materials); 0-2 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.
Nice to Have
- Certified Packaging Professional (CPP) preferred.
- Experience with ethylene oxide, steam, liquid chemical, and radiation sterilization methods
- Experience with 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 and change control software