Senior Packaging Engineer I

About the role

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Think differently and challenge what's possible.

Essential Duties And Responsibilities

• Lead the planning, design, development, and improvement of package systems for sterile and non-sterile medical devices.
• Ensure medical device packaging meets defined requirements for end user functionality, safety, manufacturability, regulatory compliance, sustainability, and business objectives.
• Define and refine design requirements, performance criteria, and business needs through cross-functional collaboration.
• 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.
• Independently execute assigned project tasks with guidance, including documentation, coordination with team members, and execution of defined methodologies.
• 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 workstreams, including training and coordination of assigned tasks.

Desired Minimum Qualifications

• 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
• Familiarity with FDA, ISO, ASTM, and ISTA requirements for packaging and labeling
• Solid understanding of packaging materials, structures, components, and related conversion processes
• 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
• 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

• Microsoft Office software and tools (Outlook, Project, Powerpoint, Word, & Excel)
• Statistical tools

Physical Requirements

• Repetitively sit, listen, and speak
• Periodically lift and/or move up to 20lbs

Pay Range

$81,650.00 - $112,700.00 USD

Additional Description for Pay Transparency

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Additional Information

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.