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Packaging Engineer Boulder CO Location: US-CO-Boulder Email this job to a friend
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Job Title: Packaging Engineer Location: Boulder, CO Job Description: - 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.
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