Packaging Engineer
: Job Details :

Job Summary:

This position is responsible for investigating, leading, planning, developing and implementing the packaging / labeling projects in support of new products and existing operations. Involved with leading projects of varied scope requiring engineering team or cross-functional team effort. Provides support to existing packaging / labeling operations and equipment.

Job Details:

1. Maintain and follow TMC Quality System requirements; including but not limited to understanding of change control, validation, documentation practices, and design control requirements.

2. Collaborate and maintain cross-functional partnerships with other departments such as Design and Technology, Quality, Regulatory, Marketing, Manufacturing

3. Support multiple projects simultaneously

4. Provide day to day support on existing packaging / labeling processes and equipment

5. Capable of leading and executing packaging / labeling related projects from design through validation

6. Plan work schedules, expenditures, attend meetings, coordinate resources and prepare reports as required, ensuring effective communication of ideas, information, and issues to appropriate stakeholders

7. Provide engineering input in the design, fabrication, development, installation, validation and qualification of packaging / labeling equipment and software which may include feasibility studies and/or proper documentation for justification of project and training to ensure proper operation of the equipment

8. Provide technical assistance and leadership in the planning and implementation of packaging / labeling projects to develop, install, and qualify new processes for manufacturing or improving existing processes

9. Maintains high awareness of technical trends and developments in the packaging industry

10. Assist in the completion of engineering tasks or projects for higher lever engineers.

11. May be necessary to coordinate the activities of support groups such as purchasing, scheduling, production, etc. Collecting of data from various sections.

12. Performs other job related duties assigned.

Knoweldge, Skills, and Abilities (KSAs)

· Excellent knowledge of packaging test methodology

· Excellent understanding of packaging materials' capabilities and equipment

· Thorough understanding of medical device processes and effect on packaging preferred

· Able to analyze all aspects of package systems

· Excellent analytical and problem solving skills.

· Familiar with of statistical techniques used in developing samples sizes preferred.

· Experience with equipment and process validations, including development of protocols and execution of protocols.

· Successful experience leading project teams is preferred.

· Thorough knowledge of equipment and tools in laboratory testing and inspection systems.

· Thorough understanding of physical and structure package testing procedures.

· Knowledge of GMP/FDA regulations preferred.

· Ability to create and work from engineering drawings.

· Excellent communication skills both verbal and written.

Background Experiences

· BS in packaging, mechanical, or related engineering field with 3+ yrs relevant work experience in the packaging, medical or regulated industry preferred.

· Experience in a manufacturing environment for designing, specifying, assembling, and validating packaging / labeling equipment, processes, and software.