Salary: £30K - £35K Pa, dependent on experience
Benefits Package: 20 days paid holiday (and all UK Bank Holidays), Company Profit Share, Shares in the business and opportunity to buy more shares, payment protection and more.
Premier Engineering has engaged with a key client and a leading Manufacturer in the biopharmaceutical industry. Our client is based in Ceredigion. Due to continuous business growth an opportunity has become available for a Process Engineer to join the business excellence and manufacturing engineering department.
My client is looking for a completer finisher who works under the Principal Process Engineer to deliver the qualification, verification and validation of processes through the build and test process of highly technical and specialised products.
With the creation of a new department, they are looking for a candidate with a strong Mechanical background.
Main Duties and Responsibilities:
- Product and process validation and verification of new and existing products, as well as the creation of supporting documentation (including installation qualification/operational qualification documents, operating procedures, quality control procedures and test procedures).
- PFMEA, process flow, lean manufacturing plan, manufacturing instructions & packaging processes.
- Work with new product development teams to advise on the design for manufacture of new products, turning their build instructions into processes and procedures suitable for mass manufacture to be followed by our manufacturing department.
- Undertake and oversee the build of pre-production batches of parts to analyse the build process.
- As part of the Manufacturing handover process, you will be expected to train
- Manufacturing staff on new processes, such as delicate mechanical assembly, soldering, board programming and calibration.
- Work with the Manufacturing department to deliver the changes needed to enable their continuous improvement program.
- Help the Quality department to understand the quality requirements for new products and work with manufacturers to ensure that these standards are met. Work with our software team to automate existing processes, including the implementation of robotics and cobots.
- Design, build and specification of jigs, tools and equipment.
- Identify process problems and non-conformances in manufacturing processes and
- develop corrective actions.
- Set up and maintain products, BoMs and suppliers in our MRP system.
- Work within an ISO 9001 & 13485 environment.
- Work with the development team to identify and specify replacement parts and components for obsolete parts.
Knowledge, Skills and Experience Required:
- Experience in product and process Validation and Verification.
- Degree or equivalent HND in Electronics or Mechanical Engineering or related subject Ability to manage time effectively, prioritise tasks and achieve set targets working effectively independently and as part of a team.
- Excellent communicator
- Design of jigs and fixtures using CAD (preferably Solidworks)
- Attention to detail and a drive to deliver quality products
- Ability to travel (UK and occasionally internationally)
- Practical build skills and experience with workshop tools including lathe, mill, laser cutters and 3d printer
- Knowledge of injection moulding and over moulding processes
- Computer literacy and proficiency in Microsoft office suite (Word, Excel & Publisher)
- Experience of specialist glues and adhesives
- Design for and programming of CNC
- Familiarity with high end engineering polymers
- Understanding of CE/EMC compliance principles
- Experience with injection moulded parts
- Familiarity with MRP
- Project planning and time management
- Medical device industry experience
- Experience of hands on and training of technicians on new processes
- Experience of remote training of technicians on new processes
- Cleanroom experience
- Familiarity with PFMEA, process flow, manufacturing plans
- Expertise with statistical process control (SPC, CPK’s etc.)
If you could be interested in the role as a Process Engineer, please apply with your latest CV and call Jeremy at Premier Engineering on 0121 796 1888 for further information.