Packaging Enigneer

Job Title: Packaging Engineer

Location: Irvine, CA

Duration: Long Term

Job Description:

We are looking for a talented Packaging Engineer to join our team for a medical device client. This role will focus on the development, design, and optimization of packaging solutions for medical device products, ensuring compliance with industry standards and regulations. You will be integral in ensuring that products are packaged to maintain quality, safety, and performance during storage and transportation.

Key responsibilities include:

• Designing and developing packaging solutions for medical devices, ensuring compliance with regulatory standards (ISO 13485, FDA, etc.).
• Performing packaging validation, including stability, shipping, and environmental testing, to ensure product protection and safety.
• Collaborating with cross-functional teams including R&D, Manufacturing, Quality Assurance, and Regulatory to define packaging requirements and specifications.
• Supporting the development and maintenance of packaging specifications and technical documentation (e.g., labels, drawings, specifications).
• Leading packaging material selection, ensuring cost-effectiveness, and optimizing for manufacturing efficiency.
• Conducting risk assessments and failure mode effects analysis (FMEA) for packaging designs.
• Ensuring packaging designs meet customer requirements and are optimized for distribution and regulatory compliance.
• Reviewing and approving packaging change requests and supporting design transfer to manufacturing.
• Participating in design reviews and ensuring adherence to quality management systems (QMS).

Qualifications:

• Bachelor’s degree in Packaging Engineering, Mechanical Engineering, or a related field.
• 3+ years of experience in packaging engineering, preferably in the medical device or regulated industries.
• Strong knowledge of medical device packaging regulations (ISO 13485, FDA, and other relevant standards).
• Experience with packaging design, material selection, and packaging testing (stability, shipping, and environmental).
• Familiarity with packaging validation, documentation, and regulatory submissions.
• Proficiency in design software (SolidWorks, AutoCAD, etc.) and packaging testing equipment.
• Strong problem-solving skills and the ability to work collaboratively in a cross-functional team environment.
• Excellent communication skills, both written and verbal.