Job Title: Manufacturing Engineer
Location: Cork, Ireland
Type : Permanent
Job Duties | Generic
· End to end support of Manufacturing process validation Define the execution strategy to validate the manufacturing process
· Perform statistical analysis to prove the manufacturing process capability
· Identifying key tasks, prepare and manage schedule, resource management and periodical review with senior management
· Drive the overall delivery Responsibility of the project.
· Monitor and improve team performance
· Responsible for verifying and validation of several machines and various process involved in it.
· Responsible for IQ/OQ/PQ methodologies and report generation.
· Preparing document in business process by identifying the business requirements.
· Understanding functional specifications and system design specifications for client engagements.
· Analyse issues recurrence to identify patterns and gaps identification, drive root cause
· analysis, and translate findings into solutions to improve workflows, processes and tools
· Interaction with manufacturing and design team to identify improvement areas in
· manufacturing process
· Interaction with supply chain management team related to manufacturing activities
· Implementation and follow the operational standards, policies and procedures.
· Optimization of manufacturing processes and methodologies
· Mitigate risks reported during the project
· Documentation of process change in engineering change management system
· Technical guidance and coordination with offshore team to execute project
Educational qualification required to perform the job : Bachelor's degree, or 3 years equivalent work experience
Work Experience required to perform the job
· Experience in Foundry process and investment casting process.
· Experience in PLM process and releasing the documents.
· Experience in change control process.
· Experience in process validation and process verification activities.
· Experience in mould qualification and CMM programming.
· Experience in test method development, test method validation, test protocol preparation, test
setup preparation and test execution.
· Planning and co-ordination with the offshore team on the project front.
· Ability to establish highly collaborative relationships; strong communication and project
Skills / Knowledge required to perform the job
· Exposure to ISO13485 and ISO14971 medical standards and have exposure to risk assessment techniques to evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
· Knowledge of Unigraphics.
· Experience in test method development validation, development and transfer.
· Experience in stages of qualification like design, installation, operational and performance.
· Experience in preparing test plan documents and standard test method development.
· Experience in preparing manufacturing process control flow chart.
· Experience in Risk management and Change management process.
· Hands on experience in creation of Pareto chart, why-why analysis, cause & effect diagram for analysis.