Salary: £43K - £48K 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 Principal Process Engineer to join the business excellence and manufacturing engineering department.
You will be a completer finisher who will lead a process engineering team responsible for the qualification, verification and validation of processes through the build, calibration and test stages of highly technical and specialised products.
My client is looking for a combination of skills so will consider candidates with an electronics or 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.
- Accountability for the timely progression and delivery of new products, working with the R&D manager to plan work and reporting back on progress.
- 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.
- Support internal and external audits.
- Work with the development team to identify and specify replacement parts and components for obsolete parts
Knowledge, Skills and Experience Required:
- Ability to lead a team
- Degree in Electronics Engineering, Mechanical Engineering or related subject
- Extensive experience in product and process Validation and Verification
- Attention to detail and a drive to deliver quality products
- Project planning and time management
- Ability to manage time effectively, prioritise tasks and achieve set targets.
- Excellent communicator
- Familiarity with PFMEA, process flow, manufacturing plans
- An understanding of electronic and RF principles
- Computer literacy and proficiency in Microsoft office suite (Word, Excel & Publisher)
- Electronics assembly and soldering proficiency – surface mount & through hole
- Ability to travel (UK and occasionally internationally) Understanding of CE/EMC compliance principles
- Familiarity with MRP
- Expertise with statistical process control (SPC, CPK’s etc.)
- Programming experience – electrical/mechanical hardware interfacing, electronics component control and programming (via PLC or otherwise)
- Medical device industry experience
- Design for and programming of CNC
- Experience with injection moulded parts
- Experience of specialist glues and adhesives
- Experience of hands on and training of technicians on new processes
- Experience of remote training of technicians on new processes
- Cleanroom experience
- Experience with workshop tools including lathe, mill, laser cutters and 3d printer
If you could be interested in the role as a Principal Process Engineer, please apply with your latest CV and call Jeremy at Premier Engineering on 0121 796 1888 for further information.