Senior Packaging Engineer

Senior Packaging Engineer ISkip to main content

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Privacy Policy# Integra Life Sciences Careers Senior Packaging Engineer I page is loaded## Senior Packaging Engineer IApplylocations:
US-MD-Columbia-NA-Facility time type:
Full time posted on:
Posted Todayjob requisition :
JR-6436

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.
** 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.
* 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 work streams, including training and coordination of assigned tasks.
** 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 8+ years of experience or equivalent education and years of experience
* Master degree with 5+ years of experience or equivalent education and years of experience
* Doctoral degree with 3+ years of experience or equivalent education and years of experience
** Minimum Expected Qualifications
*** 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…