- Entry level
- No Education
- Salary £30,000.00 - £40,000.00 gross per year
Medical Devices Manufacturer based in Wales seeks an experienced Process Development Engineer
St Asaph (Wales)
Primary Role: To transfer, develop and improve new and existing processes used in the manufacture of miniaturised electrochemical biosensor. This will involve working with ultra-low volume dispensing, die & wire bond, assembly, calibration and test processes. To ensure manufacturing facility remains in compliance as required to maintain ISO13485 quality standard. Improve efficiency, increase yield and reduce the cost of goods of production processes. Design, source and implement the optimum production equipment, processes and associated facilities for the manufacture of product range This will require management of several projects on manual, semi-automatic and automatic assembly. Also final packaging and testing. Also detailed analysis of yield & capacity and implementation of an improvement program. This will necessitate a sound ability in the production, monitoring and communication of plans and budgets. Also, the strong communication with, and management of, external partners.
Other Roles: Organise equipment acceptance testing and subsequent validation. Advise the product development group on DFM requirements. Attend design and risks assessments. Production of the associated documentation. Co-ordinate and support of the Company's product development, operations and marketing activities and facilities as requested from time to time. Project related (or departmental budget) financial management as requested from time to time.
Skills: Knowledge and practice of six sigma methods GMP PFMEA Minitab Basic statistical analysis Process & Equipment Validation Basic project management skills Knowledge of the principles of lean manufacturing Problem solving / Root cause analysis Appreciation and understanding of DfX (DfM/DfA) Design of jigs and fixtures Knowledge of pneumatics & reasonable understanding of control systems Developing manual assembly methods & procedures HVAC / Clean room specification & build knowledge highly desirable Automated machine specification and acquisition Must be able to demonstrate the successful management of external suppliers Knowledge of sterilisation methods Highly competent with both Microsoft Excel and Project MSA / GR&R
Personal Attributes: Highly self-motivated Confident communicator at all levels Team player Well organised Willingness to travel and spend time at the Cambridge facility. To support and develop manufacturing processes still based in Cambridge prior to any transfer to North Wales. Full UK driving licence Own a car
Education : HND / Degree in an Engineering discipline (probably mechanical, manufacturing or Chemical)
Experience : Ideally a minimum of five years' experience in a similar role within the medical device industry. Preferably at two different companies. Experience of working within quality systems essential. E.g. ISO 9001 or 13485 Process Transfer Microfluidics Ultra low volume dispensing (=Nano litre) Vision systems Optical metrology & topography
- iso 9001
- microsoft excel
- ms project