A highly innovative medical device manufacturer in the Newport area currently require a contract Process/Manufacturing Engineer to join their team on an initial 6 month contract. This company are genuinely revolutionising certain applications within their field and the successful candidate/contractor will be working on high tech, innovative products which will have a huge impact on people’s lives.
The role will be assisting with qualification, verification and validation of processes through the build and test process of a high tech and innovative medical device.
They are open to both an hourly/daily rate contract or a 6-month fixed term position. On offer is a highly competitive rate. The successful candidate/contractor should be an experienced Process/Manufacturing Engineer within the medical device industry and be a validation expert.
Responsibilities:
Product and process Validation and Verification - including IQ/OQ/PQ, DOE and TMQs
PFMEA, MVP, Process flow, manufacturing plan, manufacturing instructions, manufacturing travellers & packaging processes
Design of jigs and fixtures using SolidWorks
Manufacturing of devices containing small parts and low volume manufacturing
Identify process problems and non-conformance’s in manufacturing processes and develop corrective actions
Define and perform maintenance and calibration procedures
Drive continuous and process improvements
Support internal audits and work under ISO 13485
Review procedures for accuracy and make updates using a Document Change Order to reflect process changes, and develop production procedures, standard operating procedures testing and inspection and drawings
Participate in New Product Development teams to establish quality standards for new products and create process procedures, specifications and work instructions as needed and support new product launches
Implement GMP (Good Manufacturing Practices) & GDP (Good Documentation Practice) throughout manufacturing
Coordinate the training of Manufacturing Operators and act as a mentor and technical resource
Development of manufacturing and verification of jigs and fixtures
Experience/Skills:
Expert in product and process Validation and Verification - including IQ/OQ/PQ, DOE and TMQs.
Experience within the medical device industry is essential
Familiar with PFMEA, MVP, Process flow, manufacturing plan, manufacturing instructions, manufacturing travellers & packaging processes
Expertise with statistical process control (SPC, CPK’s etc.)
Excellent engineering and root cause analysis problems solving skills
Cleanroom experience (ISO class 7/8)
Familiarity with ISO 13485
SolidWorks experience