Ref. no.: MK/38340/IJP
Tags: Leitrim Leitrim jobs Engineer Process Engineer Process
Location(s): Leinster Leitrim
Salary range (€): Negotiable
Additional benefits:
Minimum experience required: 3 - 4 Years
Employment type: Permanent Full-time
Minimum qualification: Third Level Degree
Contact person: Michelle Kilcar
Contact e-mail: michelle@ccprecruit.ie
Job description: Process Engineer Required Qualifications/Experience/Skills: Third level Qualification in Engineering or Science, preferably in Mechanical or Medical. Ideally 2-3 years previous experience in Medical Devices/HealthCare Environment. Duties: This involves but is not limited to: · Development and 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.