Our client, a medical device company in Cork are currently looking to recruit a Manufacturing Engineer for their site.
The successful candidate for this Manufacturing Engineer role will provide Engineering support to a process, project or function. Know and apply fundamental Engineering and Quality Management System concepts, practices and procedures.
Key Responsibilities of the Manufacturing Engineer
- 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 scale ups.
- 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 New product Development Process.
- Process validation for products and processes; VP, IQ, OQ, PQ and associated documentation.
- Conduct Gauge R&R studies for products and new processes.
- Carry out structured problem solving.
- Application and development of statistical tools for use in driving continuous improvement projects.
- Provision of out-of-hours support to the business as required by management or as mandated by shutdowns and/or equipment failures.
- Level 8 Degree in Engineering, Science or related discipline or equivalent Technical experience.
- Has 1 - 2 years' experience in a manufacturing 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 stakeholders.
- 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 a 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 A.O, Quality, etc.
For further information on this Manufacturing Engineer role in please contact Roisin MacNamara on 091730022 / firstname.lastname@example.org
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