Packaging Engineer

Roles and Responsibilities: 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. Nice to have: Packaging Professional Certifications like CPP from IoPP, EU MDR knowledge and work experience. Prefered : Bachelor's Degree in Mechanical Engineering or Packaging Engineering with Medical Devices industry experience of 3 to 10 years. Job Types: Contract, Full-time Pay: $40.00 per hour Schedule: 8 hour shift Day shift Ability to commute/relocate: Boulder, CO 80302: Reliably commute or planning to relocate before starting work (Required) Work Location: In person