Senior Packaging Development Engineer I

Integra LifeSciences Corporation; Columbia (MD); Hybrid; USD 82,000 - 113,000; Full time

Job summary

Integra LifeSciences Corporation in Columbia, MD seeks a Senior Packaging Development Engineer I to lead package systems for sterile and non-sterile medical devices, supporting NPI, sustaining, and validation activities. You will design, test, and document packaging solutions in a fast-paced environment.

Reporting to Packaging Engineering, you will collaborate across R&D, Regulatory, Quality, and Operations, apply ISO 11607 and QSR principles, perform DOE and data analysis, and mentor junior

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.
• Solid understanding of packaging materials, structures, components, and related conversion processes.
• Ability to read and interpret engineering drawings, with exposure to GD&T methodologies.
• Strong working knowledge and application of statistical analysis methods such as DOE, ANOVA, capability analysis, histograms, and normality testing.
• 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.

Responsibilities

• Lead the planning, design, development, and improvement of package systems for sterile and non-sterile medical devices.
• Ensure packaging meets requirements for functionality, safety, manufacturability, regulatory compliance, and sustainability.
• Collaborate with R&D, Quality, Regulatory, Labeling, Operations, and suppliers across product lifecycle.
• Lead or contribute to packaging initiatives focused on quality, cost, and standard work.
• Apply knowledge of packaging materials, processes, and test methods to support projects.
• Execute tasks with guidance and increase independence over time.
• Develop and evaluate packaging concepts and provide technical direction.
• Plan and execute DOE activities to support development and validation.
• Prepare technical reports and documentation summarizing test results and conclusions.

Skills

QSR/GMP

Design Controls

Process Validation

DOE/ANOVA

GD&T

Technical writing

Cross-functional

Education

Bachelor +5 yrs exp

Master +3 yrs exp

PhD +0-2 yrs exp

Tools

Microsoft Office

Statistical software

GD&T tools

Job description

## Senior Packaging Development Engineer IApply: US-MD-Columbia-NA-Facility: US-MA-Braintree-220-Facility: US-MA-Mansfield-190-Facility: US-PR-Anasco-165-Facility: Full time: Posted Today: JR-6772Changing 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 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.**TOOLS AND EQUIPMENT USED*** Be fully versed in the use or Microsoft Office software and tools (Outlook, Project, PowerPoint, Word, & Excel) and use of statistical tools. **PHYSICAL REQUIREMENTS**The physical requirements listed in this section include, but are not limited to, the motor/physical abilities and skills required of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, and speak. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 20lbs.**ADVERSE WORKING CONDITIONS**The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of the position, which is that of a general plant environment.**SELECTION GUIDELINES**Formal application, rating of education and experience; oral interview and reference check; job related tests may be required.**DISCLAIMER**The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.#LI-NN1Salary Pay Range:$81,650.00 - $112,700.00 USD Salary