Packaging Engineer
4 days ago
We are seeking a skilled Packaging Engineer to join our team at Intellectt Inc. in Boulder, CO. As a Packaging Engineer, you will be responsible for designing and developing packaging solutions for medical devices, ensuring compliance with regulatory requirements and industry standards.
Key Responsibilities:- Develop and implement packaging solutions that meet regulatory requirements and industry standards.
- Design packaging configurations and materials that protect products during storage, transportation, and distribution.
- Conduct packaging testing and validation activities to evaluate performance under various environmental conditions and transportation hazards.
- Generate and maintain GMP documentation, including packaging specifications, test protocols, and reports.
- Collaborate with cross-functional teams to integrate packaging requirements into product development and manufacturing processes.
- Provide technical expertise and support during regulatory submissions and audits related to packaging.
- Continuously evaluate and improve packaging designs and processes to enhance efficiency and cost-effectiveness.
- Bachelor's degree in Packaging Engineering, Mechanical Engineering, or related field.
- 2+ years of experience in packaging engineering within the Medical Device industry.
- Familiarity with ISO 11607 standards for sterile barrier packaging and distribution.
- Experience in packaging design software (e.g., SolidWorks, CAD) and testing equipment (e.g., seal strength tester, vibration table).
- Knowledge of GMP (Good Manufacturing Practices) and regulatory requirements (e.g., FDA regulations).
- Strong analytical and problem-solving skills, with attention to detail.
- Effective communication skills, both written and verbal, to collaborate with internal teams and external stakeholders.
- Certification in Packaging (e.g., Certified Packaging Professional, CPP).
- Experience with sterile medical device packaging and aseptic processing.
- Knowledge of sustainability practices in packaging design.
- Project management skills to manage timelines and deliverables.
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