Process Engineer

Process Engineer - Medical Technology - Oxfordshire

SRG are partnering with an ambitious and innovative medical device company that is based in the Oxford area. They are in the search for individuals that have worked within the manufacturing and process engineering of medical devices. If you are looking for an opportunity to grow, develop and move up the ranks of a fast-expanding company this role is for you. Offering a competitive salary with share options and a bonus scheme.

Key responsibilities

* Design, develop, modify, and commission new equipment.

* Generate URS documents, CAD drawings and manage IQ/OQ testing.

* Monitor equipment and processes to identify improvement areas. Failure mode analysis and trend analysis.

* Improve existing processes to increase scale, productivity and/or product quality. Update SOPs.

* Develop new production processes. Generate SOPs, qualification and validation reports and process monitoring plans.

* Provide technical support to early stage product development teams through to any established products and processes.

* Ensure all activities are performed in accordance with ISO 13485.

* Provide training for manufacturing team members.

* Raise NC reports and carry out root cause analysis on non-conforming process or components in line with the defined CAPA process.Required experience

* At least 3 years in a medical device or related industry including project management experience.

* Relevant engineering degree.

* A proven record of designing, specifying and procuring custom parts or machines.

* Six sigma or similar experience.

* Knowledge/ experience with Medical Device standards (ISO 13485 / QMS / FDA 21 CFR Part 11 etc).