Our client, a medical device company in Limerick are currently looking to recruit a Senior Manufacturing Engineer for their site.
- Ensure quality of process and product as defined in appropriate OS and Material specifications.
- Ensure GMPs and system safety.
- Participate in FMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches.
- Support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
- Provide training for manufacturing team members.
- Interface with Materials Science, Design and Quality Assurance departments to provide customer with a quality product in a timely manner.
- Validation, Appraisal and support of coating suppliers, machining suppliers and raw material suppliers e.g. Forgings, titanium etc.
- Communicate and participate in system and process troubleshooting with support team members and with external agents.
- Lead and participate cross functional and cross divisional process improvement initiatives.
- Provide engineering support for New Product and new process introduction, ensuring that all activities are completed and documented in accordance with the new product Development Process.
- Process validation for new products and processes; VP, IQ, OQ, PQ and associated documentation.
- Conduct Gauge R&R studies for new products and new processes.
- Application and development of statistical tools for use in driving continuous improvement projects.
- Complete capability studies for in process inspection and generate subsequent Inspection documentation.
- All other duties as assigned.
Qualifications, Knowledge and Skills
- Degree in Mechanical Engineering or equivalent is required.
- The individual must have a minimum of 2 years? experience in an engineering role preferably within a CNC environment.
- Business understanding of operations and there impacts essential.
- High level of PC Skills required.
- Flexibility essential.
- Strong communication skills with both Internal and external agents.
- Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
- The individual should enjoy working in an aggressive, dynamic and results motivated team environment.
- Experience in an FDA regulated or regulated industry beneficial.
- Experience in a six sigma and Lean Manufacturing environment with proven improvement results.
- Green or Black Belt 6 Sigma qualifications.
- Ability to effectively work cross-functionally with Product Dev., Quality, etc.
For further information on this Senior Manufacturing Engineer role in Limerick please contact Deirdre Finnerty on 091730022 / email@example.com
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