EU MDR Packaging Engineer 1
Develops and coordinates packaging projects, including sterile and non-sterile packaging system designs, package process, package testing, and specification of materials to ensure proper configuration requirements. Responsible for ensuring that packaging is functional, cost effective, and promotes the needs of the customer and desired company image. Maintains an awareness of current packaging and sterilization advances and technologies relative to medical devices and/or other health care products.
The Packaging Engineer will work closely with Smith & Nephew cross-functional teams to develop packaging designs in support of R&D, Marketing, Quality, Regulatory, and Operations, per the guidelines of ISO 11607-1 and Smith & Nephew procedures. This position will report to the EU MDR Workstream Leader, Global Labeling & Packaging Technology.
ESSENTIAL FUNCTIONS (60%)
- Designs packaging components and develops packaging systems for existing products and/or product lines in compliance with industry and Smith & Nephew standards under general supervision with routine opportunity for individual action.
- Works under supervision from senior engineers with significant opportunity for individual action.
- Establishes appropriate project schedules and prepares project reports periodically to outline progress.
- Ensure all packaging projects are compliant with regulatory and corporate guidelines.
- Works with the labeling and graphics team to assist in the development and implementation of Instructions for Use (IFU) and labeling for Packaging Systems.
- Communicates effectively with cross functional teams, such as R&D, Marketing, Clinical, Regulatory Affairs, Quality Assurance, Purchasing, and Operations
- Develops protocols and reports for packaging feasibility studies and Design Verification Studies for legacy/sustaining products.
- Reviews and approves all packaging/labeling specifications and other technical documentation for assigned product lines.
- Works effectively with Smith & Nephew packaging suppliers.
- Prepares reports/documentation using good documentation practices and effectively communicates results cross-functionally and vertically within the organization.
- Develops material specifications for package components and raw materials.
- Develops effective working network with outside vendors and manufacturers in order to leverage their resources in implementing packaging initiatives.
- Responsible for packaging development of products when devices are not consistent with current packaging applications
- Other duties as assigned
Packaging Sustaining (40%)
- Creates and reviews Engineering Change Requests for packaging for design changes
- Effectively works with manufacturing process teams to implement new design changes quickly and effectively
- Assists in the development of standardized test procedures, polices, and standards
- Assists business initiative packaging projects as required
Approximately 10% may be required to support function/project or attend packaging events.
Bachelor’s degree in Packaging Engineering/Science or related technical area
Internship/Co-op experience preferred at minimum. Knowledge of ISO 11607 preferred. Exposure or experience of Medical Device Packaging preferred.
- Project and Time Management skills required.
- Strong communication skills required.
- Able to work independently and within cross functional team environment.
- Basic Solid works/AutoCAD skills preferred, but not required.
- Understanding of ISO, ISTA, and ASTM standards required
Ability to lift up to 30 lbs., sitting for extended periods of time at a desk, CAD terminal, or at meetings
No sponsorship will be provided for this position.
Smith & Nephew is an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.