Packaging Engineer

Description

• Designs, develops, and tests a wide variety of containers used for the protection, display, and handling of products.
• Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering.
• Quality / Process Control / Assurance of Medical Devices
• Use scientific problem solving methodologies e.g. DMAIC, process map.
• Designs package exteriors considering such factors as product identification, Operating Room Workflow, aesthetic quality, printing and production techniques.
• Manufacturing, Packaging and Laboratory Equipment
• The role will include managing OEM Packaging opportunities for distributed products and / or development of sterile and non-sterile case and tray packaging for spinal implants and instruments. This includes the Design History File documentation to support the development activities.
• Change control of Medical Devices
• Lead team to define goals, provide solutions and align on path forward, drive/track/communicate progress, adapt as needed with team.
• Leading a cross functional teams and leveraging solid PM skills e.g. project planning, communication, risk management, etc. Work collaboratively and with respect & humility with a cross functional team to drive project execution for medical devices, prioritizing safety, quality service, on-time execution.
• Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities/plants

Requirements

• Six Sigma/ Design for Six Sigma experience, and/or knowledge of Process Excellence tools. Working knowledge of SolidWorks or other packaging CAD programs (i.e., TOPS, SolidWorks, CREO, etc.).
• Experience with medical devices sterilization methods (i.e., ethylene oxide, radiation, etc.) Experience implementing appropriate risk mitigation actions with knowledge of packaging or process and process Risk Management as per FDA & ISO standards.
• Experience with Minitab or other statistical software.
• Technical experience (Trouble shooting) or any similar experience or background
• Project Management skills, including MS Project timeline and design history file management
• Read and understand quality management system documents that provide details of business processes to be used and comply with those procedures.
• Medical device design, development & manufacturing, experience of products with electrical functionality an advantage
• Computer System Validation (CSV)
• Attention to detail, accuracy, to ensure own work meets required standard (compliant to quality management system, grounded in scientific facts and/or data, within safety/scope/schedule/cost guidance).
• Examples of critical thinking and proven project execution
• Years’ Experience Required: 2yr required; however, 4 to 7 years of experience preferred.
• CREO drawing software
• Understand priority, drive critical path, and monitor secondary critical paths for progress, communicate early any challenges

Benefits

The expected salary range for this position is between $55,000 to $1,00,000 annually. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in role, base salary of internal peers, prior performance, business line, and geographic/office location.

Training + Development

Interview process

Visa Sponsorship

Security clearance