Packaging Engineer III

JOB DESCRIPTION

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 key responsibility of this position is to exercise medical device packaging subject matter expertise, sound judgement, and initiative while adhering to defined procedures during project support & improvements.

• Develop and analyze sterile or non-sterile barrier components and assemblies for medical devices.
• Participate in project teams for packaging/product design and development, test of materials, preparation of specifications, process capability studies, report preparation, and process/test documentation.
• Initiate and lead proposed packaging design changes, systematically and thoroughly analyzed through proper justification and/or data collection for verification of performance requirements.
• Plan and schedule own activities necessary to meet project timelines.
• Work cross-functionally with project management, quality, R&D, manufacturing engineering, regulatory, operations, label designers, and marketing to ensure project success.
• Design, qualify, and procure packaging components with external suppliers.
• 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.
• Provide packaging material and design technical expertise for multiple packaging configuration types.
• Assist in creating and editing labeling templates and implementation of those changes to documents to support production.
• Deliver communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.
• Work on special projects as they arise.

• Proficient with ISO 13485, FDA Design Control, CAPA, SCAR, and audit procedures.
• Proficient in packaging engineering, structured problem solving, use of statistical tools.
• Proficient knowledge of external packaging standards and methods such as ISO 11607-1, ISO 11607-2, ASTM D4169.
• Knowledge of the Medical Device Industry and familiarity with FDA QSR regulations.
• Solid Works knowledge to interpret part dimensions, sectional views, interface with product or components, and tolerance analysis.

• Bachelor’s degree from an accredited college or university (Engineering or Technology), preferably in Packaging Engineering.
• 5+ years of experience.

• This job operates in a professional office environment and routinely uses standard office equipment with frequent work performed in a clean room environment.
• May be required to sit or stand for long periods of time.
• Must be able to occasionally move and lift objects of up to 25 lbs.
• Typically requires travel less than 5% of the time.

ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges. With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now 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. We’re ready to bring you consistent quality, innovation, and value in more areas than ever.

Our focus allows us to bring you dedicated and non-dedicated IV sets and needle free connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.

ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status. If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at

• Mid-Senior level

• Full-time

• Engineering and Information Technology

• Medical Equipment Manufacturing