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Packaging Engineer II

Company: Integra Life Sciences
Location: Columbia
Posted on: September 16, 2021

Job Description:

Insight Global is looking for a Packaging Engineer II to join a Product Development team at large medical device client. The packaging engineer will be responsible for assisting in all aspects of design development and testing packaging systems for medical devices in compliance with the FDA Quality System Requirements. These duties include developing sterile barrier system, detailed specifications and tolerances, material selection, supplier selection, labeling, secondary packaging configurations, test methods development, and IQ /OQ/PQ protocols and reports. This position will also assist with packaging equipment selection, procurement, installation, process development, and qualification. In addition, this position is responsible for assisting with operation of on-site package testing laboratory including sample preparation, test execution and reporting. Support New Product Initiative projects in packaging relating activities; meeting corporate and FDA design controls requirements. Design and implement sterile barrier system for Class I through Class III terminally sterile medical devices. Create and review documents including specifications, drawings, standard operating procedures, protocols, and reports. Writes and performs IQs, OQs, PQs and Design Specifications for packaging equipment. Interface with Manufacturing, Quality, Regulatory, Research & Development, Sales, Marketing, and outside vendors to accomplish assigned tasks. Develops material specifications for package components and raw materials, and prepares process specifications for appropriate processes, including protocol development and related testing. Participate/ author Failure Mode Effects Analysis (FMEA) and other risk assessments documents for packaging related components and processes. Collaborate with Quality to ensure compliance to appropriate ISO/FDA regulations for the design, testing, documentation, and manufacturing of the companys products. This position will also be required on-site 2-3 times a week and 15%-25% travel to lab locations on the East Coast.

Experienced with sterile biological or biomaterial medical products

Class I-III Medical Device experience

Masters Degree in Package Engineering or related Engineering discipline
3+ years experience as a Packaging Engineer in Medical Device Industry

Experienced with Design Specifications/Control, Change Control, Validation/Testing

ISO 11607 (Sterilized Med Dev Packaging), ASTM and ITSA methodology

Proficient in MS Visio, SolidWorks, ArtisoCAD and barcode generation software (i.e. Loftware, Bartender)

Bachelors Degree in Package Engineering or related Engineering discipline

Open to 15%-25% Travel

Keywords: Integra Life Sciences, Baltimore , Packaging Engineer II, Other , Columbia, Maryland

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