£40000 - £45000 per annum, Benefits: Healthcare package, health insurance, pension, 25 days annual leave
+44 (0)151 666 8943
7 months ago
The role is for a Process Engineer working for a large Medical device / equipment manufacturer within the Product Development and Engineering Department. The focus of the role involves developing, troubleshooting and refining medical device manufacturing processes and equipment. The ideal candidate should have experience of process development and optimisation, validation, production support within GMP environment and lean /six sigma methodologies.
Essential Duties and Responsibilities:
- Responsible for provision of all aspects of sustaining engineering following product introduction
- Provide technical input/support for new and existing products, product enhancements and the introduction of product line extensions
- Identify opportunities to improve cost, quality and productivity across relevant processes
- Ensure that all manufacturing methods, processes, equipment and test equipment are designed to provide optimal products in terms of performance, quality and cost
- Active involvement in manufacturing projects to improve process using six sigma and lean methodology
- Application of process optimisation and statistical process control techniques e.g. DOE, Process Capability, Process Control Plans
- Investigation of non-conformance issues, implement solutions, report and present to Quality for closure
- Execute experiments required to support process development and manufacturing activities
- Involvement in process improvement activities within the production area.
- Develop and execute equipment qualification and process validation activities, protocols and reports.
- Ensure that validation requirements are adequately defined, implemented and completed where required
- Provide input to risk management processes - perform engineering investigations, conduct PFMEA's and be a voice of knowledge for process development, problem solving, issue resolution and risk mitigation
- Keep abreast of manufacturing technological developments - ensure that all manufacturers, manufacturing processes and equipment comply with relevant national & international technical specifications
- Breadth & Depth of experience:
- Sound knowledge of GMP.
- Significant level of project engineering or project management experience gained ideally within a medical device manufacturing environment.
- Experience of validation life cycle - equipment, process, cleaning, utilities.
- Ability to deliver process validation plans and the requisite documentation requirements.
- Knowledge of Lean, Six Sigma and Operational Excellence.
- Proven problem-solving skills.
- Medical Devices or Pharmaceutical sector knowledge.
- Proficient in relevant product and process development processes.
- Ability to operate effectively within a highly regulated environment and ideally experience gained within a medical device quality system.
- Educated to degree level (or equivalent) in a technical or engineering discipline.
- Fully proficient with Microsoft Project, Excel and Word and ideally a working knowledge of business systems (e.g. JDE).
- Project Management qualification, Lean & Six Sigma training. Working knowledge of CAD/CAM systems.
Scantec specialises in the Manufacturing, IT, Technical, Engineering and Scientific Sectors. Scantec provide highly qualified and experienced personnel in a compliant and professional manner on both a permanent and temporary assignment basis.
Due to the high volume of applications Scantec receives it is not always possible to acknowledge every application. Shortlisted applicants will be contacted within 28 days. If you don’t hear from us within 28 days your application has not been shortlisted at this time, to be considered for future vacancies please register with us on our website.