Senior Packaging Engineer I
Senior Packaging Engineer I
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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 whats possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
Reporting to the Manager of Packaging Engineering for Tissue Technologies the Senior Packaging Engineer I will take an individual contributor senior level role with packaging projects and possess the ability to influence with multifunctional high performing teams in a fastpaced environment. This individual will be responsible for specifications documentation and package testing in support of New Production Introduction (NPI) Sustaining and Continuous Improvement projects. In addition this position is responsible for assisting with the operation of the Integra Lifesciences onsite package testing laboratory including sample preparation test and reporting.
ESSENTIAL FUNCTIONS OF THE POSITION:
Team member of projects involving design and manufacturing resources both internal and external. Specific expectations include:
PACKAGING DEVELOPMENT
- Responsible for the planning design development validation and improvement of package systems for sterile and nonsterile medical devices with a focus towards innovation sustainability and usability that align with team and company objectives.
- Responsible for ensuring medical device packaging meets or exceeds requirements for end user functionality safety manufacturability regulatory sustainability and business and program objectives.
- Establishes design requirements performance and business criteria through collaboration with health care providers internal cross functional groups program management and packaging team members.
- Work as the lead engineer by collaborating with R&D Quality Regulatory Labeling Operations suppliers and others to design develop validate and implement package systems from exploratory through product commercialization.
- Leads strategic initiatives within the packaging team with focus on best practices stake holder value quality and cost effectiveness standard work and design and technical rigor
- Proven independent technical team member. This includes but is not limited to knowledge of project management skills ability to coordinate with crossfunctional teams technical knowledge of various medical grade material and suppliers use of design and manufacturing methodologies risk analysis testing method development and package system validation.
TOOLING AND EQUIPMENT:
- Shall assist in developing packaging concepts using internal and external resources.
- Understanding of ergonomics as related to repetitive stress injuries.
- Define and track project tooling and equipment schedule and cost.
- Responsible for proper installation of new equipment and preventative maintenance plans.
VERIFICATION AND VALIDATION:
- Experience in generating test plans writing protocols conducting design verification/validation and processing validation for package testing is required.
- Executes package testing and maintains complete records of packaging process and equipment design activities test data and other pertinent information for each project.
- Able to define statistical sample sizes as related to variable and attribute data based on established company and industry standards.
- Responsible for developing detailed process qualification strategies Process Characterization IQ OQ and PQ for packaging equipment.
- Analyze data identify root causes draw conclusions and generate reports that encompass data driven conclusions.
QUALIFICAITONS
- A bachelors degree in Packaging Engineering or a related Science field advanced degree is preferred.
- 57 years of experience a M.S. degree with 35 years of experience; a Ph.D. with 2 years of experience or comparable indepth knowledge of materials and processes used in construction and manufacturing of medical device packaging (thermoform tray pouches operation of sealing equipment etc. is required.
- Solid understanding of a broad spectrum of packaging materials structures components and related conversion processes is required.
- Extensive knowledge of FDA ISO ASTM and ISTA requirements related to packaging and labeling and how to apply them is required. Standards include at minimum ISO 11607 ISO 13487 ISO 17025 FDA 21 CFR part 820.
- Generate detail specifications using GD&T methodologies
Technical Leadership skills are required; Project Management skills are preferred - Ability to prioritize multiple rapidly changing priorities with minimal direction is required
- Strong technical writing/documentation skills are preferred.
- High level of written and verbal communications skills
- Proficient is computer software programs such as SolidWorks ArtisoCAD and barcode generation software (Bartender Loftware Labelview etc..
- Proficient PC skills (MS Word MS Excel MS Project MS Visio).
Travel Requirement
- Travel as needed 15 25 (domestic and international)
Physical Requirements
- Ability to sit for extended periods
- Ability to work on computer for extended periods
- Ability to lift and carry 50 lbs.
- Ability to work in a laboratory environment including meeting OSHA and cGLP requirements.
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.
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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 or call us at.
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Required Experience:
Senior IC
Employment Type
Full-Time
