Process Development Engineer
Our client, a medical device company in Galway are currently looking to recruit a Process Development Engineer for their site.
- Based in Galway
- Reporting to Process Development Manager
- Develop, optimise and validate new product manufacturing processes. Support the improvement of existing processes with focus on product quality, cost and performance.
- Work with the product development department and support the product design process through to product launch.
- Using Design for Manufacture (DFM) and Design for Assembly (DFA) principles, develop product manufacturing processes to ensure that best practices are established to achieve the most efficient, cost effective process, while maintaining product quality, cost and performance.
- Review and approve manufacturing process to manufacture product. Support the development of all relevant work instructions, test methods, inspection methods, Bills of Material (BOMs), routings, etc as part of definition of the final manufacturing process. Leads initial qualification.
- Work with part manufacturers to ensure that best manufacturing practices are established.
- Work with Quality Assurance (QA) to establish appropriate product sampling and inspection to ensure product quality.
- Work with Sustaining Engineering team to introduce improvements to product manufacturing process with focus on quality, cost and performance.
- Subject Matter Expert on Root Cause Analysis (RCA) and process improvement techniques (Six Sigma, Lean, etc.).
- Provide assistance and leadership as required on technical challenges and advocate that all engineers follow a standardised approach to issue resolution.
- Lead initial validations to ensure that appropriate process operating windows are established resulting in a robust manufacturing process.
- Review and support propagations of existing validated products and processes.
- University degree in mechanical engineering/material/science discipline or related.
- Minimum 7 years’ process development experience, preferably in medical devices.
- Knowledge of ISO 9000/13485/14000 etc.
- Proficiency in Six Sigma, root cause analysis and problems solving techniques.
- Certification as a Six Sigma Practitioner (Green Belt, Black Belt) is an advantage.
- Demonstrated experience of project management is an advantage.
- Demonstrated experience of process validation is essential.
- Demonstrated strong experience of solving manufacturing process/product problems is essential.
- Proficient with all Microsoft Office applications.
- Proficiency with a statistical software package (e.g. Minitab) is an advantage.
- Excellent communication and presentation skills required.
For further information on this Process Development Engineer role in Galway please contact Caroline Kingston on 086 8395531 / firstname.lastname@example.org
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