MDR- Packaging Engineer

Job Title- MDR- Packaging Engineer

Location- Lafayette, CO (Onsite)

Duration- 12 Month+ Contract

Pay Range-$50 to $50/hr.

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.

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

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