Offer summary

Qualifications:

B.S. in Packaging Engineering or related engineering discipline, 7+ years of experience in packaging within the medical device industry, Advanced knowledge of ISO13485 and ISO11607 standards, Proficiency in CAD software and understanding of FDA regulations..

Key responsabilities:

Design and improve packaging and manufacturing processes

Manage projects from feasibility through installation and validation

Develop validation plans and generate necessary protocols and reports

Troubleshoot packaging-related issues and ensure compliance with regulatory guidelines.

Job description

Summary
Our client, a manufacturer of medical devices for the dental industry, requires a packaging engineer to support a packaging project. This project will include designing, developing, and validating package design. The consultant will be responsible for developing and coordinating the requirements and specifications for new packaging equipment. They will work in a cross-functional product development environment and develop solutions required to solve complex engineering problems.

Job Duties

Assists in the design of new packages and improvement of designs and manufacturing processes
Review and understand equipment specifications as supplied by equipment vendors. Management of project from feasibility concept through installation and validation.
Supports the generation of prototype samples to evaluate new materials and design concepts.
Assists the Risk Analysis role for the package design, process design and process FMEAs.
Assists with and develops comprehensive validation plans, and generates protocol and reports.
Identifies new technologies that will provide innovation and product differentiation.
Supports Packaging Development-related quality improvement initiatives.
Ensure packaging projects comply with regulatory and corporate guidelines. Maintain compliance and knowledge of systems and procedures with the FDA regulations regarding package development.
Contribute to the troubleshooting in the resolution of packaging-related issues in manufacturing and the field.
Maintain a knowledge base that is consistent with FDA regulations

Requirements

B.S. in Packaging Engineering or Engineering discipline
7+ years of Packaging experience in the medical device industry.
Possess own CAD Software
Advanced knowledge of ISO13485 (Design Controls) and ISO11607 (Packaging Validation).
Advanced knowledge of packaging and regulatory standards that drive the medical device industry.
Knowledge of medical device manufacturing systems and material specifications for packaging
A thorough understanding of 21 CFR 820 and Process Validation
Human Factors Knowledge
Injection Plastic Molding experience
Ability to analyze and develop new testing criteria and requirements.
Identify customer requirements for new package designs.
Understanding of economical/cost-effective solutions regarding new designs.

Preferred Qualifications