Packaging Engineer

MDR- Packaging Engineer

Lafayette, CO (Onsite)

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 :

JOB DESCRIPTION

Top 3 technical skills that are required for the role :