Bill of Materials (BOM), Cleanroom, Contract Manufacturing, Cross-Functional, Manufacturing, Medical Equipment, Medical Protocols, Medicine, Microsoft Office, Problem Solving Skills, Process Capability, Product Development, Product Management, Product Packaging, Product Testing, Project Planning, Quality Control, Risk, Statistics, Sterilization, Supply Chain, Validation Plan, Vendor/Supplier Planning
SUMMARY: The position of Sterile Packaging Engineer is responsible for the creation of validation protocols, technical justification rationales, procedures, instructions, and forms that affect cleaning, passivation, sterile packaging, labeling, clean room and clean line process monitoring, sterilization, and biocompatibility according to Medical Device Standards for use by Red Star Contract Manufacturing and customers. This position works cross-functionally with quality, manufacturing, and supply chain partners from DHF (Design History File) development to design transfer of DMR (Device Master Record) and then through manufacturing, cleaning, sterile packaging, sterilization and to shelf DHR (Device History Record). The primary focus is to support the sterile packaging division and ensure that each sterile packed kit meets all requirements for biocompatibility and that the packaging withstands both shelf life and distribution testing.
ESSENTIAL DUTIES AND RESPONSIBILITIES: (includes the following but other duties may be assigned)
- Audit BOM's and DFEMA's for correlation of critical features in design for sterile packaging during design transfer
- Perform design transfer activities including development of Control Plans with Supplier, ensuring all critical parameters captured and controlled according to process risk and capability
- Evaluate new products, packaging, or process changes to mitigate any potential increased risk for sterility and packaging integrity
- Ensure through assessment that validations are current and complete with each sterile packaging facility
- Protocols are written to Medical Device Standards and the execution of the validations are complete without any open non-conformance
- Monitor and manage biocompatibility with product development, suppliers, and sterile packaging facilities
QUALIFICATION REQUIREMENTS:
- Bachelor's Degree in engineering-related field, preferably in sterile packaging engineering
- Understanding of quality control, manufacturing, validation, and statistics in a medical device setting
OTHER SKILLS and ABILITIES:
- Proficient in creative problem solving and communication
- Proficient in Microsoft Office
- Project planning experience
- Self-motivation