Title: Packaging Validation Engineer IV
Location: Cordova, TN
Job Type: 6 Month Contract
Responsible for the review and remediation for existing technical files to ensure the Packaging requirements meet the EU MDR regulations. Designs and develops packaging components and packaging systems for new and existing medical device products and/or product lines (sterile and non-sterile). Works under limited supervision with significant opportunity for individual action. Reports to the MDR Work Stream Leader of Labeling Operations & Global Packaging Technology.
ESSENTIAL JOB FUNCTIONS:
- Review and perform Gap analysis assessments for product technical files relating to packaging data & validations for existing medical device products undergoing MDR review & remediation.
- Address identified gaps in technical file data via product equivalency justifications and/or performing and reporting the required testing in accordance with the relevant standards.
- Design/re-design package components and develops packaging systems for new and existing medical device products and/or product lines with limited supervision and routine opportunity for individual action.
- Coordinates and monitors packaging projects and programs from inception through implementation.
- Establishes appropriate project schedules and prepares project reports periodically to outline progress.
- Defines applicable testing protocols and conducts or coordinates appropriate package testing as required.
- Responsible for writing, reviewing, and approving of Protocols and Reports (internal and external).
- Defines packaging-related requirements through consultation with internal and external personnel. Communicates with RDQ, Commercial, Tech Comm, Product Development & Regulatory to coordinate packaging and labeling requirements for products being developed or modified/remediated.
- Coordinates with Regulatory Affairs and Quality Assurance the requirements for package inserts, Q.C. procedures, testing for packages and/or packaging materials, labeling for IDE submissions, etc.
- Consults with appropriate vendors as required regarding technical aspects of packaging engineering projects.
- Reviews and approves all packaging/labeling specifications and other technical documentation for assigned product lines.
- Develops preliminary engineering drawings for new package designs as required utilizing company CAD system, and reviews final engineering drawings prior to approval.
- Develops material specifications for package components and raw materials, and prepares process specifications for appropriate packaging processes
- Works with Regulatory & Labeling to ensure that product packaging meets applicable regulatory and industry requirements, i.e., ISTA, ISO 11607, FDA, ASTM, European MDR, Japanese MHLW, etc.
- Bachelor’s degree in Packaging Engineering/Science or a related technical area; Master’s degree preferred
- Four years (4) experience in packaging engineering related to the design, development, and implementation of medical device or health care product packaging; two years (2) experience with a Master’s degree.
- Experience utilizing CAD system for package design applications is preferred.
- Familiar with ISO 11607-1 and 2.
- Technical writing skills