Our client is seeking to hire a Packaging Engineering Manager to support new product development and cross functional packaging operation teams supporting an FDA regulated Class II & Class III manufacturing plant.

Required Education and Experience:

• Undergraduate in a relevant sciences discipline with 10+ year of experience in packaging engineering in a manufacturing operation.
• 5+ years of recent experience leading packing engineering teams.
• Supported the design and process methods development strategies in a medical devices in an FDA regulated environment
• Advanced knowledge of CFR part 20 and ISO 11607 regulatory compliance standards
• Extensive experience developing validation and verification protocols for packaging testing
• Understanding of mechanical design/3D modeling, GD&T, and statistical process control methods
• Ability to conduct FMEA, IQ/OQ/PQ, and risk analysis on new and existing packaging processes
• Provide guidance and mentorship to colleagues as well as recommendation to management
• Collaborate with executive leadership to map out current and future strategies in order to support the companies growth

Preferred Education/Experience:

• Undergraduate degree in engineering with 8+ years of leading design and process development as a packaging engineer in an FDA regulated environment
• Rigid and/or flexible packaging design associated with implantable medical devices.
• Previous oversight of design, development, and implementation of new packaging and the automation of processes
• Supervision of 3+ packaging professionals, engineering and/or technicians, supporting cross functional operations