Packaging Engineer III

About the role

This position is 100% onsite at our Dublin, OH manufacturing facility. The Packaging Engineer III will own and drive packaging-related deliverables, including new development, design changes, and process improvements through adherence to established design control processes, good engineering and documentation practices. The role requires medical device packaging subject matter expertise, sound judgement, and initiative while adhering to defined procedures during project support and improvements.

Responsibilities

• Develop and analyze sterile or non-sterile barrier components and assemblies for medical devices.
• Fully participate in and contribute to project teams, including packaging/product design and development, test of materials, preparation of specifications, process capability studies, report preparation, and process/test documentation (including PFMEAs).
• Initiate and lead proposed packaging design changes, systematically analyzed through proper justification and/or data collection for verification of performance requirements with adherence to program-management guidelines.
• Work independently to plan and schedule activities necessary to meet project timelines.
• Collaborate cross-functionally with project management, quality, R&D, manufacturing engineering, regulatory, operations, label designers, and marketing to ensure project success.
• Work with external suppliers to design, qualify, and procure packaging components.
• Complete packaging testing and/or investigatory bench study experiments for commercial design improvements.
• Own and manage CAPA tasks and deliverables (Corrective and Preventive) as assigned.
• Assist in vendor assessment and review of materials/machine technical information.
• Identify and implement process and product modifications to improve manufacturability and profitability.
• Consult with Operations and Quality Engineers on in-process packaging-related non-conformances.
• Serve as the packaging material and design technical expert for multiple packaging configuration types.
• Assist in creating and editing labeling templates and implementing those changes to documents supporting Production.
• Deliver communications tailored to the needs of the receiver (managers, peers, customers) to maximize utility and promote cross-functional collaboration.
• Bring substantive conflicts and disagreements into the open and attempt to resolve them collaboratively; build consensus.
• Work on special projects as they arise.
• Spearhead initiatives for continuous process improvements (longer-term expectation).
• Develop a broad understanding of the product packaging manufacturing process from start to end.
• Perform design assessments, actively participate in design reviews, and engage in risk management processes.
• Network with senior internal and external personnel.
• Manage training for new and current employees regarding documentation, use of equipment, laboratory techniques, and department procedures.

Requirements

• Bachelor’s degree from an accredited college or university in Engineering or Technology, preferably in Packaging Engineering.
• 5+ years of experience in packaging engineering.
• Proficient with ISO 13485, FDA Design Control, CAPA, SCAR, and audit procedures.
• Proficient in packaging engineering, structured problem-solving, and use of statistical tools.
• Proficient knowledge of external packaging standards and methods such as ISO 11607-1, ISO 11607-2, ASTM D4169, etc.
• Knowledge of the Medical Device Industry and familiarity with FDA QSR regulations.
• SolidWorks knowledge to interpret part dimensions, sectional views, interface with product or components, and tolerance analysis.

Physical Requirements and Work Environment

This job operates in a professional office environment and routinely uses standard office equipment, with frequent work performed in a clean room environment. The employee may be required to sit or stand for long periods of time and must be able to occasionally move and lift objects of up to 25 lbs. Travel is typically less than 5% of the time.

About Us

ICU Medical is a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings. Our focus includes dedicated and non-dedicated IV sets, needlefree connectors, IV smart pumps, and IV medication safety software providing full IV-EHR interoperability. We maintain significant US IV solutions manufacturing and supply capabilities.