Process Development Engineer

Job Title: Process Development Engineer

Salary: £30 to £35 per hour depending on experience

Contract: 12 Month+

Industry: Medical

Location: Oxford

A great opportunity has arisen for a Contract Process Development Engineer to join a specialist medical device development company. The Process Development Engineer will be involved in the specification & introduction of new processes & equipment, working within the Operations team. The Process Development Engineer will need to have experience within Medical Device or Pharmaceutical processes - planning, managing & executing new processes & process improvements projects.

The appointed Process Development Engineer will need to carry out the following key duties/responsibilities:

Design & Development
• Transferring products from development to production, in conjunction with the Development Team
• Procurement of development materials, specifying standards on materials
• Development of production tooling & equipment
• Design & build of initial prototypes
• Implementation of new process & equipment
• Optimisation & validation of Production Processes
• Process FMEA's
Purchasing
• Resolving problems within manufacturing
• Writing & updating of work instructions
• Control of production documentation
• Maintenance & calibration of production tooling & instruments
• Change note implementation
• Training of new production staff - Maintenance & training records for the production staff
• Identifying new technology for product & process efficiency
• Fault finding & rectification of equipment
• Zero production stoppages
• Technical support to subcontractors
• Management of Portable Appliance Testing
Quality
• Acceptance & rejection of raw materials, sub-assemblies & final assemblies
• Control of changes to production processes including concession control
• Comply with ISO 13485 regulations
Health & Safety
• Reviewing overall health & safety of all activities with which you are involved
• Carry out risk assessment for production equipment & tooling
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The selected Process Development Engineer will need to possess the following attributes for the role:

• Practical experience & a good working knowledge of process development in a medical/pharmaceutical device environment
• ISO9001:2000 & GMP
• HNC/Degree in Production/Process Engineering
• Knowledge of Continuous Improvement techniquesOrion Electrotech Ltd acts as both an Employment Business and Employment Agency and complies with the Conduct of Employment Agencies and Employment Businesses Regulations Act 2003.