Process Engineer - medical devices

Ref No. 21842
Wales - Monmouthshire
Posted 28 Oct 2020

Overview

Salary: Please contact us

Employment: Permanent

Job description

A highly innovative medical device manufacturer in the Newport area currently require a Process Engineer to join their team. This company are genuinely revolutionising their field and the successful candidate 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 products.

On offer is a highly competitive salary and benefits package. The successful candidate 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.
Medical device industry experience is essential for the role
Expertise with statistical process control (SPC, CPK’s etc.)
Excellent engineering and root cause analysis problems solving skills
Familiar with PFMEA, MVP, Process flow, manufacturing plan, manufacturing instructions, manufacturing travellers & packaging processes
Cleanroom experience (ISO class 7/8)
Familiarity with ISO 13485
SolidWorks experience

Your consultant

Richard Andrews

Engineering Team Lead

Get in touch:

r.andrews@intapeople.com