Sr. Packaging Engineer – Endologix – Irvine, CA
Packaging Engineer responsible for the development and design of all new packaging products in support of New Product Development and current manufacturing.
• Hands on leadership and execution of all packaging engineering activities.
• Package design, development, validation and implementation
• Technical ownership of the companies packaging and labeling equipment and systems.
• Partner with Quality Engineering on the testing and validation of all new / changed packages.
• Coordinate with Production and Supply Chain to implement new packages and/or new packaging/labeling equipment
• Leadership and coordination of all Labeling related projects.
• Coordinate cross functional activities (primarily Marketing, Clinical and R&D) to establish content and translation requirements.
• Coordinate cross functional activities to ensure labeling compliance (with Regulatory and Quality Assurance) and compatibility with company systems.
• Manage external service providers (i.e. Translation) to ensure on time, on budget execution.
• Lead/coordinate execution of implementation activities for new or updated labeling.
• Documentation & Drafting Services
• Lead direct report(s), contracted resources and other assigned internal resources to execute technical product documentation (drafting, modeling, procedures, etc.) to support project completion per timelines.
• Identify and implement best practices.
• Support company goals and objectives, policies and procedures, and FDA regulations
Requires a Bachelor of Science degree in Engineering or related technical degree (i.e. physics or mathematics)
• Requires a minimum of 8 years related packaging and labeling experience.
• Experience with catheter and interventional delivery system packaging is required.
• Preffered experience to include; Cold Chain, GS1 Compliance, RFID and sterilization methods (EtO, VHP, Gamma and E-Beam)
• Must be familiar with medical device labeling control and software.
• Strong background in process/product validation.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
• Has the ability to use statistic techniques when analyzing data and make rational and logical decisions based on that analysis.
• Applicable knowledge of Minitab, JMP, or other statistic tools.
• Applicable knowledge of Solidworks or other CAD software (not a requirement but a desirable skill).
• Ability to handle multiple tasks simultaneously and ability to mange project timelines.