Our client, a medical device company in Galway are currently looking to recruit a Senior Engineer for their site.
- Lead complex projects from initial concept to final validation, aligned to PM BOK standards.
- Planning, budgeting and leading of continuous improvement and /or new product/process based projects.
- Taking responsibility for integrating the Vertebral Documentation / Product Portfolio to Merit Standards
- Continually assessing and reviewing day to day manufacturing issues / practises, consistently striving for improvement by analysing, developing and implementing manufacturing techniques and materials to provide robust improvements in compliance with FDA and regulatory requirements.
- Working independently and leading project teams or working as part of an overall project team on specific assignment objectives, complex features and possible solutions.
- Plans, organizes and provides direction to engineers, technicians and Production personnel, as required.
- Provide input and direction to management on various technical issues.
- Generates ECN (Engineering Change Notices), Protocols and prototypes under broad direction.
- Performs other related duties and tasks as required.
- Degree in Engineering or related technical field.
- At least 7 years previous related experience, or which at least 2yrs in a supervising capacity.
- Formal project management training an advantage.
- Working knowledge of Product and Process development, Risk Management, Design Validation and Regulatory Systems
- Experience dealing with Marketing, Clinical and Regulatory personnel and enhancing feedback to device concepts
- Good working knowledge of medical device materials and processes.
- Experience dealing with Marketing, Clinical and Regulatory personnel..
- Demonstrated analytical problem solving abilities including working knowledge of Statistics and associated tools.
- Ability to manage cross functional teams.
- Demonstrated experience of applying Lean tools / Six Sigma techniques to improve business processes & performance. Green Belt or Black Belt certification an advantage.
- Strong interpersonal and organizational skills and the ability to work effectively as a team member.
For further information on this Senior Engineer role in Galway please contact Caroline Kingston on 0868395531 / firstname.lastname@example.org
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