Senior Packaging Engineer I

Integra-Lifesciences; Maryland; On-site; USD 81,650 - 112,700; Full time

Job summary

Integra LifeSciences is seeking an experienced packaging engineer to lead the design, development, and improvement of packaging systems for sterile and non-sterile medical devices. You will work across R&D, Quality, Regulatory, and Operations to ensure packaging meets safety, functionality, and regulatory standards.

The role requires strong knowledge of QSR/GMP, ISO/ISTA standards, and GD&T drawing interpretation, with experience in DOE and other statistical methods to support decisions.

Qualifications

• Strong knowledge of QSR, GMP, Design Controls, and basic Process Validation in the medical device industry.
• Familiarity with FDA, ISO, ASTM, ISTA requirements for packaging and labeling, ISO 11607, ISO 13485, ISO 14971.
• Ability to read and interpret engineering drawings with GD&T concepts.
• Experience applying statistical analysis methods (DOE, ANOVA, capability analysis, histograms, normality testing) to engineering decisions.

Responsibilities

• Lead planning, design, development, and improvement of packaging systems for sterile and non-sterile devices.
• Ensure packaging meets end-user functionality, safety, manufacturability, regulatory compliance, and sustainability requirements.
• Collaborate cross-functionally with R&D, Quality, Regulatory, Labeling, Operations and suppliers.
• Develop and review technical reports, protocols, and documentation summarizing test results and conclusions.
• Provide guidance to junior engineers and lead small project teams.

Skills

QSR & GMP

Design Controls

FDA/ISO/ISTA standards

Packaging materials knowledge

DOE & statistical methods

Technical writing

Cross-functional collaboration

GD&T interpretation

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Doctoral degree in Engineering

Tools

MS Office

Excel

Microsoft Project

Statistical software

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 RESPONSIBILITIESTo 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-makingIndependently 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 QUALIFICATIONSThe requirements listed below are representative of the knowledge, skill, and/or ability required.Education and Years of ExperienceBachelor degree with 8+ years of experience or equivalent education and years of experienceMaster degree with 5+ years of experience or equivalent education and years of experienceDoctoral degree with 3+ years of experience or equivalent education and years of experienceMinimum Expected QualificationsStrong 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 methodologiesAbility 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 USEDBe fully versed in the use or Microsoft Office software and tools (Outlook, Project, Powerpoint, Word, & Excel) and use of statistical tools.PHYSICAL REQUIREMENTSThe 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:$81,650.00 - $112,700.00 USD SalaryOur 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 LifeSciencesIntegra 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 VeteransIntegra 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] Agency SubmissionIntegra 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