Manufacturing Engineer - Blackburn, United Kingdom - Empty Box Recruitment Ltd
Description
Main responsibilities include:
- Perform product lifecycle changes in line with company QMS, customer requirements and the required standards and regulations.
- Support projects, in line with customer expectations and the required standards and regulations.
- Deliver projects on time and to budget, ensuring company and customer project procedures are followed.
- Ensure the appropriate transfer of products from development to pilot production phase and on to full production phase conducting all agreed realisation activities.
- Complete validation activities in line with company and customer requirements.
- Owner of NC, CAPA and in root cause analysis of process and product NC and complaints, particularly when related to product design.
- Provide technical support to Sales & Marketing team, where appropriate. Working directly with customers to discuss new projects and resolve design and process issues posttransfer.
- Identify new technologies and products that could be utilised to facilitate the successful implementation of new products or to support future business needs.
- Ensure timely escalation of issues to Line Manager and Quality where applicable.
- For all tasks, make suggestions for continuous improvement of processes and implement where applicable / requested to do so.
- Adhere to QMS, HSE policies and procedures and all other compnay policies and procedures at all times.
- Bachelor's degree or equivalent in a relevant Engineering or science discipline.
- Previous experience with creation of 3D CAD and 2D Engineering drawings (SolidWorks or similar).
- Previous experience of Design for Manufacture.
- Knowledge of Standards Applicable to Medical Devices, covering but not limited to:
- Risk Management (ISO 14971)
- Quality Management (ISO 13485)
- Awareness of Good Manufacturing Practice.
- Awareness of Packaging of medical devices.
- Awareness of change control and how to assess change requirements.
- Awareness of MS Project and / or other Project Management techniques.
- Familiarity with statistical methods.
- Good skills in written and spoken English to enable communication with colleagues and to understand technical and QMS related documents.
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