Packaging Engineer II - Exempt
- Memphis, TN
- Permanent
- Full-time
- Design, develop, and test a wide variety of containers for the protection, display, and handling of products.
- Determine packaging specifications based on product nature, cost limitations, legal requirements, and protection needs, considering external variables such as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering.
- Design package exteriors, considering factors like product identification, Operating Room Workflow, aesthetic quality, and production techniques.
- Manage documentation and coordinate Good Manufacturing Practices (GMPs), supporting prototype line development in manufacturing facilities.
- Experience in medical device design, development, and manufacturing, particularly with products having electrical functionality.
- Demonstrated critical thinking and proven project execution skills.
- Experience leading cross-functional teams with strong project management skills, including project planning, communication, and risk management.
- Familiarity with medical devices sterilization methods (e.g., ethylene oxide, radiation).
- Experience implementing risk mitigation actions with knowledge of packaging or process Risk Management as per FDA & ISO standards.
- Six Sigma/Design for Six Sigma experience, and/or knowledge of Process Excellence tools.
- Working knowledge of SolidWorks or other packaging CAD programs (e.g., TOPS, CREO).
- Experience with Minitab or other statistical software.
- Experience in change control of medical devices.
- Equipment commissioning/qualification and process validation experience.
- Computer System Validation (CSV) knowledge.
- Experience with manufacturing, packaging, and laboratory equipment.
- Technical troubleshooting experience.
- Quality/Process Control/Assurance of medical devices.
- Design Failure Mode and Effect Analysis (DFMEA) experience.
- Proficiency in CREO drawing software.
- Experience in sterile packaging and medical device packaging development.
- Project management skills, including MS Project timeline and design history file management.
- Years of Experience Required: Minimum of 2 years required; 4 to 7 years preferred.
- Work Schedule: 40 hours per week, onsite 4 days a week.