General Purpose of the Job:   

The Jr Projects and Process Engineer contributes with the definition, implementation and execution of the tactical tasks defined by the Global Operations Support Group about the Global Molding strategy and will support the drafting of technical validation documents for software or equipment to be installed in the sites of the Medical Devices Group. 

This position requires knowledge of technical writing of documents, basics of software development and mechanical principles. 

Essential Duties/ Responsibilities and Tasks: 

The Jr Projects and Process Engineer works closely with the Sr Molding Engineer and is responsible for effectively executing tasks within molding projects.  

• Definition (Initiation according to PMI) phase:  

• Participate in projects definition at a broad level beginning with a business case to ensure that the project is feasible. If the approval is obtained, project charter or project initiation documents must be issued where the purpose and requirements of the project are expressed.   

• Planning phase:  

• Understand the scope of the project and the goals that will be achieved as part of the project implementation. 

• Help develop a project management plan that includes the identification of costs, quality and resources, and the project timeline. 

• Understand the risk associated with the implementation and the action plan for mitigation actions to countermeasure the potential impacts. The knowledge of the product and process system allows effective risk identification. 

• Schedule definition: understand the project schedule based on resources and risk. 

• Execute the communication plan for internal and external stakeholders. 

• Execution phase:  

• Set kickoff meetings to inform the teams involved about their responsibilities. 

• Lead the periodic project meetings. 

• Provide report outs at least once a month. 

• Project monitoring 

• Together with the Sr Molding Engineer, it ensures that project’s plans are on track by the revision of key performance indicators around project objectives, quality deliverables, costs and budget, project performance. 

• Project Closure 

• Once finished the projects, be part of the team that reviews the project results and feedback the system with lesson learned. 

• Generate a lesson learned report per project once the project is closed. 

• Recognize valuable team members. 

Participates in the identification of new technologies by which the current molding processes could be optimized, therefore value improvement either by quality improvement or cost reduction. 

As part of the duties about the technical written of documents for validations, the Jr Projects and Process Engineer must 

• Write, and support validation documents for new or actual equipment and/or software in collaboration with cross functional teams  

• Design and write engineering studies, validation protocols, and test cases. 

• Asure compliance with FDA Quality System Regulation and Moog’s standards related to good documentation practices. 

• Creation, revision, and approval of technical content within Moog’s document management system. 

• Support global cross-functional development and/or sustaining projects. 

• Identify compliance gaps and work with Engineering and Regulatory to resolve compliance issues. 

• Support cross-functional projects to improve and maintain compliant, effective, and efficient quality processes. 

• Maintain up-to-date knowledge of regulatory requirements, international standards, and company QMS procedures for areas of responsibility. 

• Complete required training in a timely manner. 

Therefore, this position must develop: 

• Knowledge of product and process systems. 

• Project management skills. 

• Six sigma analysis and capabilities.  

• FDA Quality System Regulation and Moog’s standards