Process Engineer

CPL

Leitrim

Process Engineer required with medical device industry background required. You will be working in a team of engineers on the latest technology. Main background required: Third level Qualification in Engineering or Science, preferably in Mechanical or Medical. Ideally 2-3 yr. previous experience in an Medical Devices / HealthCare Environment. Main Requirements: Development & maintenance of process & tooling including providing specifications and procedures in accordance with the requirements of ISO 13485 (2003) & MEDDEV 93/42/EEC. Ensuring that the necessary testing, evaluation & control of equipment measures are in place to monitor & support product quality in accordance with the requirements of ISO 13485 (2003) & MEDDEV 93/42/EEC. Ensuring that new product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485 (2003) & MEDDEV 93/42/EEC. Identifying and specifying materials, processes, tooling and equipment for new products. Organising and/or completing IQ’s, OQ’s and PQ’s and ensuring validations are completed prior to production. Problem solving and trouble shooting on Non-conforming materials, customer complaints and incapable processes. Ensuring that Processes are set up and monitored according to work instructions. Training of Technicians and Operators as required. Participation in On-going Process Improvements. Participation in the development of plant lay-outs, material travel & handling & over-all work plan in order to provide effective synchronous manufacturing. Ensuring that that non-conforming product and processes are evaluated and corrected as required in accordance with process controls and production procedures. Participation in the MRB Programme & product disposition. Participation in plant Corrective/ Preventive & Continuous Process Improvement programmes. Participation in the Internal Quality Audit Programme & Vendor Audit Programme. Participation in the Internal Validation Programme & ensuring that all new processes are validated before transfer to production. Please contact Fiona Keane at 091 507 502 or 086 027 9952 or click on the link below if you would like more information. This job originally appeared on RecruitIreland.com.

2502 days ago