Senior Packaging Development Engineer I

Essential Duties and Responsibilities

• Lead the planning, design, development, and improvement of package systems for sterile and non-sterile medical devices by executing assigned tasks using established requirements and procedures.
• Ensure medical device packaging meets defined requirements for end user functionality, safety, manufacturability, regulatory compliance, sustainability, and business objectives through application and interpretation of applicable standards and processes.
• Define and refine design requirements, performance criteria, and business needs through cross-functional collaboration, leveraging technical expertise and engineering judgment.
• Collaborate with R&D, Quality, Regulatory, Labeling, Operations, and suppliers to drive the design, development, validation, and implementation of package systems across the product lifecycle.
• Lead or contribute significantly to packaging team initiatives focused on best practices, quality improvements, cost effectiveness, and standard work, identifying opportunities for process improvement.
• Apply technical knowledge of packaging materials, processes, and test methods, including design controls, risk management, and validation principles, to support project execution and decision-making.
• Independently execute assigned project tasks with guidance, including documentation, coordination with team members, and execution of defined methodologies, with increasing independence as experience is gained.
• Develop and evaluate packaging concepts using internal and external resources, providing technical direction and recommendations.
• Plan and execute Design of Experiments (DOE) activities, including setup, data collection, and documentation, under direction, to support packaging development and validation efforts.
• Apply statistical methods and engineering judgment to analyze data, establish sample sizes, and support data-driven decisions.
• Support process validation activities with a primary focus on packaging-related inputs, including contributing to OQ and PQ execution as needed.
• Analyze data, identify trends and root causes, and develop conclusions and recommendations based on multiple sources of information.
• Prepare and review technical reports, protocols, and documentation summarizing test results, DOE outcomes, and engineering conclusions.
• Provide guidance to junior engineers and may lead small project teams or workstreams, including training and coordination of assigned tasks.

Minimum Qualifications

• Bachelor degree with 5+ years of experience or equivalent education and years of experience
• Master degree with 3+ years of experience or equivalent education and years of experience
• Doctoral degree with 0-2 years of experience or equivalent education and years of experience
• Strong knowledge of Quality System Regulation (QSR), GMP, Design Controls, and basic Process Validation principles within the medical device industry, along with familiarity with FDA, ISO, ASTM, and ISTA requirements for packaging and labeling, including the ability to apply relevant standards such as ISO 11607 (Parts 1 and 2), ISO 13485, ISO 14971, and FDA 21 CFR Part 820 using established procedures and guidance.
• Solid understanding of packaging materials, structures, components, and related conversion processes, with opportunity to build knowledge through hands-on experience.
• Ability to read and interpret engineering drawings, with exposure to GD&T methodologies
• Ability to manage multiple assigned tasks and priorities with direction, adapting to changing project needs.
• Strong working knowledge and application of statistical analysis methods such as DOE, ANOVA, capability analysis, histograms, and normality testing to support engineering decisions.
• Strong technical writing and documentation skills, with the ability to independently develop clear, accurate protocols, reports, and specifications.
• Effective written and verbal communication skills, with the ability to influence cross-functional teams and communicate technical concepts, risks, and recommendations.