Sr. Packaging Project Engineer
Develops, leads, coordinates and implements packaging process and equipment projects, including improvements to product package designs, packaging processes, and material specifications to ensure proper configuration requirements.
Researches, identifies, and pilots new technologies as well as methodologies to improve current packaging designs and packaging processes.
Proposes solutions and opportunities to management for review.
Researches and identifies packaging automation opportunities for manufacturing sites; Coordinates and implements valid solutions, after thorough vetting of each solution.
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.
Effectively coordinates capital projects, process improvements, packaging improvements, flow improvement, process standardization, regulatory compliance and cost reduction initiatives with multi-functional teams from Manufacturing, Quality, Packaging Engineering, Marketing, Facilities, Finance, and outside suppliers and equipment manufacturers.
Coordinates and monitors technically challenging packaging projects and programs from inception through implementation. Establishes appropriate project schedules and prepares project reports periodically to outline progress.
Works under limited supervision with significant opportunity for individual action.
Maintains an awareness of current packaging and sterilization advances and technologies relative to medical devices and / or other health care products.
Develops and implements testing approach for product sterilization modifications.
Responsible for ensuring that packaging for assigned product lines meet user needs, address CTQ requirements, are cost effective, and promote the desired company quality and messaging.
Lays out special projects, such as re-sterile concept for surgical devices, or packaging of new and different type items to determine overall project scope and time requirements.
Defines applicable testing protocols and conducts or coordinates appropriate package testing as required.
Writes and performs design validations, assessments and feasibility studies as needed, which may require testing on new packages as required.
Coordinates with Regulatory Affairs and Quality Assurance on the requirements for package inserts, procedures, testing for packages and / or packaging materials, labeling for IDE submissions, etc.
Communicates with Marketing and Product Development to coordinate packaging and labeling requirements for products being developed or modified.
Develops effective working network with outside vendors and manufactures in order to leverage their resources for implementing packaging initiatives.
Develops material specifications for package components and raw materials, and prepares process specifications for appropriate processes, including protocol development and related testing.
Responsible for packaging development of legacy products when devices are not consistent or compatible with current packaging applications or standards.
Maintains complete records for package related activities, including test data, and enters information into product lifecycle management system in compliance with design control processes and procedures.
As needed, may create and maintain packaging Design History Files (DHFs) in compliance with ISO 11607.
May assist or offer guidance to other packaging engineering staff and / or production packaging personnel.
Assists in the resolution of packaging-related problems with packaging suppliers and within production. Visits production environment regularly to understand and address current issues.
Investigates packaging complaints and completes root cause analysis as needed. Provides recommendations and direction based on data and medical device packaging knowledge.
Packaging design, development, sustaining, and process engineering support.
Supports key supplier transfers, quality initiatives, and packaging performance improvement projects.
Supports and aligns to the Global Packaging Technology group for direction and compliance.
Adheres to packaging compliance guidelines per ISO 11607.
Engineering Bachelor's degree(mechanical, electrical, materials, industrial, packaging or a related technical area; Master’s degree preferred.
Licenses / Certifications
Certified Packaging Professional(CPP) preferred but, not required
Minimum of five (5) years’ experience in packaging engineering related to the design and development of medical device or sterile product packaging.
Experience using CAD systems is preferred, but not required.
Project and time management, able to work independently and within cross functional team environments.