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 workstreams, 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 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.

Salary Pay Range:

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

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)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences