Sr. Packaging Engineer

Job Description

Provide technical packaging leadership and support in the areas of design and process development, testing, and scale-up of new packaging systems and processes. He/she leads or participates on cross-functional engineering assignments and provides technical packaging support to OSTA for new product and process development, manufacturing, and sustaining engineering activities.

Job Duties

• Plans and executes key package engineering assignments related to new product development, manufacturing, and sustaining activities.
• Engages in and leads packaging projects related to process development, cost saving initiatives, innovative package design, equipment standardization, and test method development.
• Determines and coordinates performance and stability testing to ensure product and package integrity for design and manufacturing through the end-user.
• Leads troubleshooting efforts for the resolution of packaging related issues for design, manufacturing, and in the field.
• Drives packaging improvements for design, processing, and functional requirements and leads the implementation activities.
• Executes packaging projects and support in compliance with government and corporate guidelines.
• Contributes to the company with inventions, new designs, and processes or techniques which are significant to the solution of critical packaging problems.
• Participates and provides technical expertise for risk assessment and compliance assurance programs for packaging.
• Assures delivery of robust, cost-effective, and fully compliant packaging solutions that meet current and evolving customers’ needs.
• Creation of packaging design requirements; such as component prints, assembly prints, and inspection criteria.
• Capable of developing packaging processes including all elements of process validation.
• Create, review, and approve internal packaging verification and validation documentation.
• Lead continuous improvement measures by providing technical information and reviewing packaging designs and processes as they are revised.
• Train operators, supervisors and other employees on use of new packaging designs, testing, equipment and/or processes.
• Train operators, supervisors and other employees on use of new packaging designs, testing, equipment and/or processes.
• Knows and follows all laws and policies that apply to one's job while maintaining the highest levels of professionalism, ethics and compliance at all times.
• All other essential duties as directed.

Job Qualifications

Required:

• Bachelor's of Science degree in science, engineering or technology discipline; a packaging engineering degree is preferred.
• Minimum of 5 years of professional experience within the medical device industry supporting packaging is required.

Preferred:

• The ideal candidate should have a successful record of supporting packaging design and process development across an organization.
• Experience working in integrated cross-functional product development teams.
• Experience developing packaging for new product development.
• Process development and/or manufacturing experience preferred.
• In-depth knowledge of ISO 11607-1/2 and how it guides requirements for packaging design, process development, manufacturing, and testing.
• Knowledge of sterile packaging design, material characteristics, and verification/validation practices.
• Must be able to support multiple project teams simultaneously, as well as lead packaging specific projects when needed.
• Demonstrated experience in executing design verification and/or process validation of packaging in the medical device industry; including technical writing of protocols and reports.
• Experience in writing and executing design verifications and/or process validations is required.
• Knowledge of and understanding of ISO13485 and its application to medical device products.
• Experience in supplier selection/management for medical device packaging materials and equipment.
• Practical application of statistical analysis and techniques, as well as Design of Experiments (DOE), is preferred.
• UNDERSTANDING OF RISK ANALYSIS AND EXPERIENCE IN THE CREATION OF DESIGN AND PROCESS FMEAS.
• The candidate must be proficient with the use of Microsoft Office applications.
• Time management skills allowing for leading or working on multiple projects at once.