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 Department and be responsible for establishing requirements for new products and subsequent transfer or implementation in Production. The job holder also drives their own projects to bring in and validate new equipment and processes.
Main responsibilities include:
- Support Engineering & Product Development project requirements for new equipment and processes by working closely with the team and Production.
- Spec new equipment and implement through the full validation lifecycle according to requirements of ISO 13485 and other SoTA and Regulations.
- Develop processes / upscale processes from lab to Production and validate (PQ).
- Support PLM and Manufacturing Engineering projects, as above.
- Create and manage Change Notes to ensure that all actions are aligned with project plans and implementation is compliant.
- Deliver projects on time and to budget, ensuring all 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 business and customer requirements.
- Owner of NCR, CAPA and in root cause analysis of process and product NC and complaints, particularly when related to Production Processes and equipment.
- Working directly with internal and external 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.
- 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 policies and procedures at all times.
The ideal candidate will have all of the following:
- Bachelor's degree or equivalent in an Engineering subject (preferred) or similar.
- Previous experience (at least 3 years) of a regulated industry (Medical Devices or Pharma preferred).
- Previous experience (at least 5 years) of working in a manufacturing environment (Medical Devices or Pharma preferred).
- Proven commercial acumen including, generation of business cases, CARs, project budgeting, cost centre tracking, quotations and quotation models etc.
- Experience of plastics and metals for use in medical devices and tooling is preferred.
- CAD user, preferably Solidworks.
- Demonstrable experience of leading multi-functional capital projects, including facility and bespoke equipment requirements for product manufacture.
- Experience of tech-transfer and design transfer requirements including product design requirements, process development, validation, change control and other functional requirements.
- Familiar with product design processes.
- Good to excellent working knowledge of ISO 13485. Beneficial to have familiarity with other medical device related standards and Regulations
- Excellent skills in written and spoken English to enable communication with colleagues and to understand technical and QMS related documents.