Packaging Engineer

Job TitleThis role involves managing OEM Packaging opportunities for distributed products and the development of sterile and non-sterile case and tray packaging for spinal implants and instruments. The position requires the creation of Design History File documentation to support development activities.Key ResponsibilitiesDesign, 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.Must Have QualificationsExperience 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.Nice to Have QualificationsExperience 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.Technical Skills RequiredProficiency 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.Experience and Work ScheduleYears of Experience Required: Minimum of 2 years required; 4 to 7 years preferred.Work Schedule: 40 hours per week, onsite 4 days a week.Product Line SupportThis position supports Spinal and Biologics products.Interview TimelineInterviews are scheduled to take place between June 30 – July 16.