What you will do: ​

• Lead the team in the development of the project charter and management plan. Direct, manage, monitor, and control project. Evaluate tradeoffs within project.
• Meet with project stakeholders to understand and refine project scope; review with manager for approval. Create detailed Work Breakdown Structure.
• Develop and manage the detailed project Gantt chart. Analyze critical path and major workstreams.
• Develop a risk management plan for the project. Identify, analyze and understand project risks, develop and monitor a risk response plan.
   

What you will need:

Required:

• University degree in engineering (or similar).
• Experience in regulated industries, such as medical devices or pharmaceuticals.
• Understanding of manufacturing processes and quality tools such as FMEA (Failure Mode and Effects Analysis), CAPA (Corrective and Preventive Actions), PPAP (Production Part Approval Process), validations, and inspections.
• Knowledge of standards such as ISO 13485 (quality standard for medical devices).
• Advanced English communication skills

           Desirable:

• Experience with Process Flow Mapping (PFM) or process risk assessment.
• Experience with non-conformity management.