Process Development Engineer
Location: North Wales
Salary: £30,000 - £40,000 DOE, bonus, healthcare and additional benefits
Our Client, a multi sited Medical Devices company are looking to recruit for an experienced Process Development Engineer; who will work as a vital part of their new production site in N.Wales and pay a key role in site developments there.
- To transfer, develop and improve new and existing processes used in the manufacture of Clients 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 Client'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 Clients production processes.
- Design, source and implement the optimum production equipment, processes and associated facilities for the manufacture of Clients 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.
- Will hold a Degree in a relevant Scientific or Engineering Discipline.
- Will have Process Transfer and Process Equipment Validation experience within a MEDICAL DEVICES (13485 dicipline)
- Knowledge and practice of six sigma methods/ knowledge of the principles of lean manufacturing
- Appreciation and understanding of DfX (DfM/DfA)
- Design of jigs and fixtures
- Knowledge of pneumatics & reasonable understanding of control systems
- HVAC / Clean room specification & build knowledge highly desirable
- Automated machine specification and acquisition
- Highly competent with both Microsoft Excel and Project