Manufacturing Engineer

Brightwater

Cork

A Medical Device client has a contract position available for a Manufacturing Engineer . This is a 2 year contract role workingprimarily on implementing change management projects in one or more of their manufacturing areas. About the Job: Initiate, co-ordinate and complete assigned projects within the engineering department, using structured approach and detailed planning to deliver projects that meet or exceed stakeholder expectations and that are delivered Right First Time, safely, on schedule and within budget. Complete Process / Product / Equipment Validations within the department as they arise, in conjunction with Quality/Validation group. Conduct process feasibility trials / process DOE’s to determine appropriate/robust process windows. Work in conjunction with the Quality & Validation group to determine appropriate validation sampling and acceptance criteria. Liaise with operations and technician group to prepare plan for validation builds. Co-ordinate the execution of OQ / PQ builds. Prepare OQ / PQ validation reports and deviations as required. Conduct process capability analysis using Minitab. Maintain and develop manufacturing process documentation and procedures. All process changes and modifications to be documented and tracked closely. Provide Technical/Engineering support manufacturing. Lead and coordinate the troubleshooting of various manufacturing process issues. Responsible for dealing with process, product and quality issues to achieve long term solutions. Regular reporting of manufacturing process performance to relevant personnel. Use of OEE line performance tools to identify and address efficiency losses. Ensure compliance with GMP and Safety rules on new and existing equipment. Lead and co-ordinate cost resolution projects year on year as per individual goals. Lead and co-ordinate Risk Mitigation initiatives such as FMEA and Risk Assessments. Thorough investigation of Quality and EHS issues using Root Cause Analysis methodology, and implementation of robust corrective and preventative actions to prevent recurrence. Working Knowledge of the following would be an advantage but not a requirement. Automated / Semi Automated assembly equipment. Injection moulding and mould tools. High precision Punch & Die Sets. Heat sealing, ultrasonic welding, leak testing, vision systems. OEE Line performance methodology. Minitab/ Lean 6 Sigma techniques. Root Cause Analysis methodology. Microsoft Excel to an advanced level. AutoCAD. About You: Minimum of a Level 8 Degree in Mechanical / Production Engineering or equivalent. Minimum of 3 years relevant experience, preferably within Medical Device industry or other regulated environments. Working knowledge of Product & Process validations essential. Excellent engineering ability. Strong organisational ability. Self motivation and drive. Demonstrate a high level of responsiveness to internal customers (eg. production. Communication- strong written, oral and presentational skills. For more on the role call Nigel on 021 4221000 or send your CV for consideration . This job originally appeared on RecruitIreland.com.

1857 days ago