PLASTICS ENGINEER A contract medical device manufacturer is looking for a time served engineer with working experience in plastics, plastics conversion, injection moulding and...
A contract medical device manufacturer is looking for a time served engineer with working experience in plastics, plastics conversion, injection moulding and extrusion. The ideal candidate may or not have a degree in engineering or related subject, NVQ, HND or other relevant qualifications.
- Running and development of tooling and processes for extrusion and injection moulding machinery.
- Provide first-line support to Production for process and equipment issues.
- Responsible for creating User Requirement Specifications and Functional Design Specifications for capital expenditure, business purchases, and other business needs such as tools and fixtures.
- Sourcing, procurement, and commissioning and installation and operational qualification of equipment (IQOQ and all required IQOQ outputs), tools, and fixtures, which may include FAT, SAT and DQ.
- Responsible for generating scientific protocols and reports and other quality system documentation.
- Conducting process development and validation in accordance with the requirements of Mi3 QMS and any specified customer requirements, and Health & Safety legal requirements, including full documentation of all trials and validations.
- Responsible for CSV of standalone or embedded computer systems/software, where applicable.
- Responsible for creating and maintaining documents such as work instructions, production work instructions in draft, pFMEA, risk assessments, SSOW's (Safe Systems of Work) training, etc.
- Provide expertise to NPD and other departments as required with support for new product introductions and new technologies, sample builds and building jigs.
- Develop and validate inspection and testing techniques and equipment where required for process development and validation.
- Responsible for training departments for processes and equipment use.
A minimum of 5 years' experience in an engineering role or setting within a regulated manufacturing company, with a preference for medical devices and ISO 13845 quality management systems, however Pharmaceutical will be viewed favorably. You will have moderate to specialised experience in plastics and/or extrusion or IM processes/machinery and will have conducted several types of process development and validation and understand the dependencies in a validation project.
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.