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Senior Packaging Engineer
1 month ago
Job Summary: Seeking a Senior Packaging Engineer responsible for designing, developing, and testing packaging solutions for medical devices. Ensure designs meet legal, quality, and cost requirements, protecting against environmental factors like moisture, chemicals, temperature, and tampering. Manage packaging design from validation to manufacturing transfer, collaborating cross-functionally.
Key Responsibilities:
- Design sterile and non-sterile medical device packaging, ensuring compliance with ASTM, ISTA, IEC, UL, FDA, and EU standards.
- Collaborate with OEMs and cross-functional teams to meet functional and regulatory requirements.
- Lead design, material qualification, verification, validation, and implementation of packaging solutions.
- Manage engineering change control, documentation, and technical reporting for packaging specifications and testing.
- Develop and revise artwork and labeling for product packaging using CAD and artwork tools.
- Utilize CAD software (e.g., Creo, SolidWorks) and Adobe Illustrator/Corel Draw for packaging design.
- Project manage multiple packaging projects, ensuring timely and quality delivery.
- Support prototype line development and manufacturing transfers with plant facilities.
- Ensure GMP and regulatory compliance in packaging solutions.
Required Qualifications:
- Bachelor’s degree in Packaging Engineering or related field with 8-12 years' experience; or Master's with 4+ years.
- Hands-on experience in packaging material qualification, testing (DFMEA, PFMEA, PPAP, DFM&A), CAD (Creo, SolidWorks), and PLM (Windchill, Agile).
- Proficient in medical device standards: FDA, EU MDR, ASTM, ISO, IEC.
- Expertise in engineering change management, documentation, and reporting.
- Strong communication and collaboration skills with stakeholders.
- Ability to manage multiple projects with strong organizational and project management skills.
Preferred Qualifications:
- GD&T certification, experience with medical device product/site transfers.
- Familiarity with packaging-related production methods, artwork/labeling tools.