Packaging Engineer

Internal Job Description section. 1 of 2.

EU MDR Packaging Engineer:

Prefered: Bachelors Degree in Mechanical Engineering or Packaging Engineering with Medical Devices industry experience of 3 to 10 years; Nice to have: Packaging Professional Certifications like CPP from IoPP, EU MDR knowledge and work experience;

Job Activities Include: • Sterile and Non-sterile Medical Device Packaging Design, Process Validation, Gap Assessment and Remediation as per EU MDR 2017/745, ISO 11607-1:2020 and ISO 11607-2:2020 requirements • Transportation Ship Testing as per ISO 11607-1:2020 and ASTM D4169:2016 requirements • Packaging Stability Testing as per ISO 11607-1:2020 requirements • Packaging Sealer Process Validation (IQ OQ PQ) as per ISO 11607-2:2020 requirements • Technical Documentation: Protocol, Report and SOP authoring covering test plan, test methods, acceptance criteria, sampling plan etc., of the above-mentioned tests. • Packaging design of sterile barriers systems and non-sterile devices; Drawings and specifications creation of tray-lids, pouches, display boxes, shippers, retainers/ insert cards etc., • Change Order Execution: Change Development Process (CDPs), Engineering Change Orders for drawings/ specifications, quality documents • Pallet Patternization • Working with cross-functional teams- Manufacturing Sites, Sterilization, Biocompatibility, Labelling, Quality, Regulatory, Testing Labs etc., globally, across business units for technical data mining, design review, implementation, and report preparation