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Manufacturing Engineer

Empty Box Recruitment Ltd
Job LocationBurnley
EducationNot Mentioned
Salary40,000 - 45,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Our client operates in the Medical Devices sector of business and the successful candidate will need to work within this regulatory framework in the Technical Quality department and be responsible for the maintenance and improvement of existing product designand manufacture, and for development and subsequent transfer of manufacturing processes. They will also have key involvement in the enquiry process, conduct product and process changes in accordance with ISO 13485, ISO 14971, MDSAP, company procedures andany other relevant standards, regulations and customer requirements.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 post-transfer.
  • 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.
The ideal candidate will have all of the following:
  • Bachelors 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:
o Risk Management (ISO 14971)o 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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