Senior Packaging Development Engineer I

Changing lives. Building Careers.   Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. Reporting to the Manager of Packaging Engineering, this successful individual will take an individual contributor role with packaging projects and possess the ability to perform in fast-paced environment. This individual will be responsible for specifications, documentation, and package testing in support of New Production Introduction (NPI), Sustaining, Packaging Process Development and Continuous Improvement projects. SUPERVISION RECEIVED Directly reports to Manager of Packaging Engineering   SUPERVISION EXERCISED None.   ESSENTIAL DUTIES AND RESPONSIBILITIES To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  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. undefined   DESIRED MINIMUM QUALIFICATIONS The requirements listed below are representative of the knowledge, skill, and/or ability required. Education and Years of Experience 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 Minimum Expected Qualifications Strong