Senior Packaging Engineer I

INTEGRA LIFESCIENCES CORP; Columbia (MD); On-site; USD 81,650 - 112,700; Full time

Benefits offered by this job

Medical

Dental

Vision

Life Insurance

Short-Term Disability

Long-Term Disability

Business Accident Insurance

Group Legal Insurance

Savings Plan (401(k))

Job summary

Integra LifeSciences is seeking a packaging engineer to lead the design and improvement of packaging systems for sterile and non-sterile medical devices. You will collaborate with R&D, Quality, Regulatory, and Operations to ensure assemblies meet safety, usability, and regulatory requirements throughout the product lifecycle.

The role requires strong knowledge of QSR, GMP, ISO standards, and DOE-based analysis, with a track record of delivering robust, cost-efficient packaging solutions.

Qualifications

• Bachelor's degree with 8+ years of experience in medical device packaging.
• Master's degree with 5+ years of experience.
• Doctoral degree with 3+ years of experience.
• Knowledge of ISO 11607, ISO 13485, FDA 21 CFR Part 820.

Responsibilities

• Lead planning, design, and improvement of packaging systems for sterile and non-sterile devices.
• Ensure packaging meets end-user, regulatory, and manufacturability requirements.
• Collaborate with R&D, Quality, Regulatory, and suppliers across product lifecycle.
• Develop concepts and provide direction for packaging strategies.
• Support validation activities, including OQ/PQ, and data-driven decisions.
• Prepare technical reports, protocols, and test results.

Skills

Packaging design

Cross-functional collaboration

Technical writing

Statistical analysis (DOE, ANOVA)

Quality systems understanding

Education

Bachelor's degree with 8+ years of experience

Master's degree with 5+ years of experience

Doctoral degree with 3+ years of experience

Tools

Microsoft Office

Job description

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

• 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

• 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

Salary Pay Range: $81,650.00 - $112,700.00 USD

Salary 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

• medical
• dental
• vision
• life insurance
• short- and long-term disability
• business accident insurance
• group legal insurance
• savings plan (401(k))

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 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.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law | EOE including Disability/Protected Veterans Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at [e-mail].

Unsolicited Agency Submission Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

Integra - Employer Branding from Integra LifeSciences on Vimeo Whatever your specialty, you’ll find an ideal setting for building a rewarding career. Along the way, you’ll have the satisfaction of knowing your work matters, that it’s making patients’ lives better, making a positive and lasting difference. You’ll find that the pace is exhilarating – because the need is so urgent. You’ll be challenged – and supported – by the most dynamic and inspiring people in your profession. And you’ll grow a career that is more impactful and fulfilling then you thought possible. More than 4,200 Integra employees already know we’re a great place to build a career. Here’s your chance to discover that for yourself.