MDR - Packaging Engineer

Job Title : MDR - Packaging Engineer Location : Lafayette, CO (Onsite) Candidates should have 3 to 4 years of experience in packaging. Job Description & Skill Requirement : Must Have :

• Medical device design, development & manufacturing, experience of products with electrical functionality an advantage
• Examples of critical thinking and proven project execution
• 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.
• Lead team to define goals, provide solutions and align on path forward, drive / track / communicate progress, adapt as needed with team.
• Read and understand quality management system documents that provide details of business processes to be used and comply with those procedures.
• Use scientific problem solving methodologies e.g. DMAIC, process map.
• whys, Is / Is not, etc. Drive solid decision making.
• 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).
• Understand priority, drive critical path, and monitor secondary critical paths for progress, communicate early any challenges
• 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.
• 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 Minitab or other statistical software. Nice to Have :
• Change control of Medical Devices
• Equipment Commissioning / Qualification
• Process Validation
• Computer System Validation (CSV)
• Manufacturing, Packaging and Laboratory Equipment
• Technical experience (Trouble shooting) or any similar experience or background
• Quality / Process Control / Assurance of Medical Devices JOB DESCRIPTION
• 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.
• Responsibilities may include the following and other duties may be assigned.
• 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.
• Designs package exteriors considering such factors as product identification, Operating Room Workflow, aesthetic quality, printing and production techniques.
• Responsibilities may include documentation management and / or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities / plants Top 3 technical skills that are required for the role :
• CREO drawing software
• Sterile Packaging / Medical Device Packaging Development
• Project Management skills, including MS Project timeline and design history file management
• Years' Experience Required : 2yr required; however, 4 to 7 years of experience preferred.