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The Principal Packaging Engineer will work within the lntegra Lifesciences Tissue Technologies R&D organization to support the packaging requirements of new and existing products. This position will provide technical expertise in the areas of medical device packaging design & development and process development & validation for new packaging equipment.

SUPERVISION RECEIVED

Reports to the Director of Packaging Development

SUPERVISION EXERCISED

None expected

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully an individual must be able to perform each essential duty satisfactorily.

Primary responsibilities are to:

• Works with Engineering and Manufacturing product teams as SME to develop and implement new device packages to improve existing package designs and to develop and improve packaging-related manufacturing processes in the Integra LifeSciences Manufacturing plants and at supplier locations.

• Works in compliance with GMP workpracticesISO 13485 and ISO11607 Standards

• Participates as the team member responsible for packaging on New Product Development projects and major packaging development projects.

• Provides expertise for all elements of packaging design testing validation & processing.

• Leads and/or participates in risk assessments and cost improvement initiatives.

• Partners with Manufacturing Quality R&D and Procurement to develop and improve packaging designs that are compliant to all containment and shipping needs of medical devices.

• Manages packaging projects with a significant scope that could involve several product codes multiple packaging materials and processes and manufacturing locations in both US and EU

• Demonstrates ability to develop track and maintain project timelines and budgets.

• Participate in projects that involve cross-functional teams as the owner of all packaging related deliverables.

• Demonstrate initiative to lead and/or participate in process improvement and task teams as needed at company and franchise levels.

• Travel as needed to domestic and international vendor sites and company locations

• Other duties as assigned

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge skill and/or ability required for this position.

• Demonstrated expertise in packaging technologies and their application in the medical device field.

• A thorough knowledge of medical device design control process.

• Ability to communicate effectively with colleagues teams management and external partners.

• Ability to collaborate with and mentor technical staff in packaging engineering discipline.

• Ability to serve as project leader for packaging related projects

Education

• Bachelors of Science in Engineering required.

• Masters of Science in Engineering preferred in Packaging Engineering

Experience:

• Minimum 12 years of experience with BS or 10 years with MS in medical device packaging engineering

• Medical device industry product design and validation process knowledge of sterile packaging material characteristics and validation practices.

• Experience in writing and executing design equipment and process validations.

• Working knowledge of ISO 13485 Design Control and ISO 11607 Standards with application to medical devices.

• Experience In supplier selection/management for medical device packaging components and equipment.

• Statistical analysis knowledge required Six Sigma certification preferred experience working in integrated cross-functional product development teams.

• Excellent verbal written and presentation skills.

TOOLS AND EQUIPMENT USED

Virtual and/or on-site office environment. Must be computer literate and familiar with Microsoft Suite of products including Project Word Excel PowerPoint Outlook Visio and other similar applications.

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include but are not limited to the motor/physical abilities and skills require of position in order to successfully undertake the essential duties and responsibilities of this 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.

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 this position.

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 and 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.

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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 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.

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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

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 candidates name resume or background) are position-specific and may only occur within the scope of that approved agreement. Please no phone calls or emails.

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