Packaging Engineer II
Company: Integra Life Sciences
Posted on: September 16, 2021
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
Class I-III Medical Device experience
Masters Degree in Package Engineering or related Engineering
3+ years experience as a Packaging Engineer in Medical Device
Experienced with Design Specifications/Control, Change Control,
ISO 11607 (Sterilized Med Dev Packaging), ASTM and ITSA
Proficient in MS Visio, SolidWorks, ArtisoCAD and barcode
generation software (i.e. Loftware, Bartender)
Bachelors Degree in Package Engineering or related Engineering
Open to 15%-25% Travel
Keywords: Integra Life Sciences, Baltimore , Packaging Engineer II, Other , Columbia, Maryland
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