Process Development Engineer (Wales)
£30,000 to £40,000 DOE
To transfer, develop and improve new and existing processes used in the manufacture of Spheres miniaturised electrochemical biosensor. This will involve working with ultra-low volume dispensing, die & wire bond, assembly, calibration and test processes.
To manage the production validation process, prepare the documentation and carry out the production validation.
To ensure Sphere’s Wales manufacturing facility remains in compliance as required to maintain ISO13485 quality standard.
Improve efficiency, increase yield and reduce the cost of goods of Spheres production processes.
Design, source and implement the optimum production equipment, processes and associated facilities for the manufacture of Spheres product range
This will require management of several projects on manual, semi-automatic and automatic assembly; 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.
Organise equipment acceptance testing.
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.
Knowledge and practice of six sigma methods
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
Confident communicator at all levels
Willingness to travel and spend time at Spheres 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
HND / Degree in an Engineering discipline (probably mechanical, manufacturing or Chemical)
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
Ultra-low volume dispensing (≤Nano litre)
Optical metrology & topography ≤µm scale
Information for recruitment agencies
As a growing company, we are aware that there are a large number of agencies looking for an opportunity to work with us. However, at present, we operate a preferred supplier list. If you are interested in working with us, please contact us via email only to: firstname.lastname@example.org
On receipt we will keep your details on file and contact you if we require assistance with a particular role.