Our client is seeking to hire a lead packaging engineer to support new product development and cross functional packaging operation teams supporting a FDA regulated Class II & Class III manufacturing plant.
If you are looking to take the next step in your career and work with team to improve operations and contribute your engineering skills to the continued success of the packaging team, apply today!
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 design and process methods and techniques for implantable 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
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
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