CONMED Corporation Sr. Packaging Engineer in Utica, New York

Duties and responsibilities include:

Design:
Develop packaging specifications and associated engineering documents
Develop packaging testing methods, perform or direct test method validations and train others to use these methods as required
Perform validation of new or modified packaging designs to appropriate and current regulatory standards
Work directly with outside suppliers to develop optimal package designs and/or components
Coordinate and communicate packaging technology and designs with project teams and management staff as part of project management and design control activities
Identify, review and evaluate new packaging technology for application to current and future product designs
Participate in development of risk analysis associated with packaging design and associated processes
Document all packaging and labeling design, development, and testing to comply with FDA design control regulations and industry standards for sterile barrier packaging systems and processes
Identify and assess new medical packaging material and perform selection and analysis
Process:
Collaborate with manufacturing engineering and manufacturing staff to design, specify, implement and validate equipment and processes required to support the packaging process
Collaborate with and/or support supplier quality engineering and manage packaging process validations with external packaging and packaging component suppliers
Collaborate with packaging vendors to evaluate and select optimal packaging technology to meet customer needs
Develop/implement production/processing methods and controls to meet quality standards in most cost efficient manner
Identify opportunities to improve packaging processes by Designing/Developing/Implementing new packaging technologies
Prepare equipment (IQ,OQ, PQ) and process performance validation (PQ) protocols and reports
Prepare operating procedures for new equipment and processes
Identify, initiate and implement projects to improve productivity and reduce scrap/reject rates through process enhancements and effective training of production personnel, and address any compliance related packaging issues
Translate end user requirements to packaging functional specifications
Develop URS/FAT, design verification, DOE/SPC process optimization and validation (IQ, OQ, PQ) and MiniTab, TOPS

CONMED is an Equal Opportunity Employer & an Affirmative Action Employer. CONMED is a strong advocate of workforce diversity. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, genetic information, disability, or veteran status.

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