ICU Medical · 1 day ago
Packaging Engineer III
Dublin, OH
Full-time
Onsite
Senior Level
5+ years expICU Medical, Inc. is seeking a Packaging Engineer III who will own and drive packaging related deliverables for medical devices. This role involves developing and analyzing packaging components, leading design changes, and collaborating cross-functionally to ensure project success.
Health CareMedical Device
Responsibilities
Responsible for the development and analysis of sterile or non-sterile barrier components and assemblies for medical devices
Fully participate in and successfully contribute to project teams typically including the following activities: 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 and thoroughly 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 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
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
Packaging material and design technical expert for multiple packaging configuration types
Assisting in creating and editing labeling templates, and implementation of those changes to documents to support Production
Receives general project direction. Responsible for project progress
Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration. Brings substantive conflicts and disagreements into the open and attempts to resolve them collaboratively; builds consensus
Work on special projects as they arise
Spearhead initiatives for continuous process improvements
Develop a broad understanding from start to end of the product packaging manufacturing process in the company
Perform design assessments, active participation in design reviews and risk management processes
Network with senior internal and external personnel
Manages training new/current employees with respect to documentation, use of equipment, laboratory techniques and department procedures
Qualification
Required
Bachelor's degree from an accredited college or university (Engineering or Technology), preferably in Packaging Engineering
5+ years of experience
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, etc
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
Company
ICU Medical
ICU Medical connects patients and caregivers through safe, life-saving, life-enhancing IV therapy systems, software, solutions, and consumables.
Founded in 2019San Clemente, California, USA
5001-10000 employees
H1B Sponsorship
ICU Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (24)
2024 (14)
2023 (27)
2022 (31)
2021 (12)
2020 (14)
Funding
Current Stage
Late StageTotal Funding
$1.3M2012-08-15Undisclosed· $1.3M
Leadership Team
Allison Knight
Human Resources Business Partner
Ben Sousa
Chief Information Officer
Company data provided by crunchbase