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The Director, Packaging Development is responsible for managing all aspects of the design, development, and validation of packages and packaging systems for medical devices at Tissue Technologies division of Integra, in compliance with applicable FDA and ISO requirements.
This individual is responsible for providing departmental technical expertise and company leadership for package development while collaborating with regulatory, marketing, market research, supply chain, process excellence and other affiliated departments and organizations to identify and address packaging needs.
These duties include managing the overall strategy for the development of sterile barrier systems and secondary packaging, creating, and maintaining detailed specifications, creating, and executing validation/qualification protocols, and responsibility for packaging equipment selection and development, material selection, supplier selection, and labeling. This position is responsible for the operation of the Columbia, Md Research & Development Packaging testing laboratory including sample preparation, test execution and reporting.
SUPERVISION RECEIVED
- Manager provides regular oversight on task/ activities related to project deliverables and timeline.
SUPERVISION EXERCISED
- Oversee and provide task/ activity guidance to engineers, department interns and lab technicians.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Manage the design, development, and qualification of packages and packaging systems for sterile and non-sterile medical devices at Integra Lifesciences.
- Articulate and drive the overall division-wide packaging strategy and develop the associated Standard Operating Procedures (SOPs) and best practices to ensure success and align to current regulations and business strategies.
- Establish and oversee timelines, budget estimates, and resource requirements for package development, sustaining and continuous improvement projects and drive the projects to successful completion.
- Mentor the Tissue Technologies R&D Packaging Engineering team members and provide project direction, prioritization, and technical oversight to ensure successful implementation of packaging strategy in support of product leadership goals.
- Support the conceptualization, initiation, development and implementation of new packages and processes including design generation, prototyping, consumer acceptance testing, engineering specifications, verification and validation, and technology transfer.
- Identify and investigate industry best practices and implementation improvements as appropriate.
- Demonstrate technical expertise on packaging, materials, and processes along with the ability to communicate that knowledge to internal and external partners.
- Oversee the overall operation of the Integra Lifesciences Columbia, Md site package testing laboratory including sample preparation, test execution and reporting.
- Prepare and maintaining the departmental policies, procedures, and manuals.
- Investigate design changes and failures, product complaints, and non-conformances, report findings and recommendations in company systems for corrective and preventive action.
- Review Failure Mode Effects Analysis (FMEA) and risk assessments for products and processes.
- Perform process validations of new and modified designs and processes.
- Collaborate with Quality to ensure compliance to appropriate ISO/FDA regulations for the design, testing, documentation, and manufacturing of the company’s products.
- Interface with Manufacturing, Quality, Regulatory, Research & Development, Sales, Marketing, and outside vendors to accomplish assigned tasks.
- Perform other duties as assigned.
Additional Responsibilities
- Demonstrate a commitment to understanding packaging and labeling related global medical device manufacturing, ISO 13485, and regulations through active participation in company training as well as through self-education by reading related articles and attending seminars.
- Work effectively on computers using Microsoft Office and Minitab statistical software to collect data, create histograms and graphs, and write protocols and reports .
DESIRED MINIMUM QUALIFICATIONS
- Minimum of a bachelor’s degree in Packaging Engineering or other engineering disciplines or possess the equivalent combination of education and experience. A master’s degree in Packaging Engineering or other engineering disciplines is preferred.
- Minimum of 15 years of experience developing and validating packaging systems for medical devices.
- Expert knowledge of the U.S. and International standards governing the design, development, testing, and manufacture of medical devices, particularly ISO 11607, ISO 13485 well as ASTM and ISTA test methods and practices.
- Expert knowledge of U.S. FDA, cGMP, and ISO requirements for the design, validation, manufacturing processes, secondary operations, and assembly of packaging systems
- Ability to drive projects with tight timelines and drive them to successful completion.
- Excellent verbal and written communication skills; ability to lead meetings and effectively present to a group.
- Demonstrate effective time management and verbal and written communication.
- Critical thinking and problem solving to develop solutions
- Knowledge of gamma, ETO, and e-beam sterilization methods
- Proficient in computer software programs such as SolidWorks, ArtisoCAD, and barcode generation software (Bartender, Loftware, etc.).
- Proficient PC skills (MS Word, MS Excel, MS Project, MS Visio).
TOOLS AND EQUIPMENT USED
- Office equipment: Computer (desktop or laptop), keyboard, mouse, desk, chair
- Measurement tools: (ruler, calipers)
- Cutting tools: scissors, precision knife, box cutter
- Packaging equipment: Vibration table, drop tester, compression tester, leak detector, tensile tester
PHYSICAL REQUIREMENTS
- Ability to sit for extended periods
- Ability to work on computer for extended periods
- Ability to lift 50 lbs.
- Ability to work in a laboratory environment, including meeting OSHA and cGLP requirements.
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, which is that of a general plant environment.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, high precarious places, toxic or caustic chemicals, risk of electrical shock and vibration. The noise level in the work environment is usually moderate.
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 an 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:
$166,750.00 - $228,850.00 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:
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 https://jobs.integralife.com/total-rewards/
Integra LifeSciences is an equal opportunity employer, and is com