Telephone: 086 3073779
Senior Manufacturing Engineer (Projects)
Our client, a company in Galway is currently looking to recruit a Senior Manufacturing Engineer (Projects)for their site.
Responsible for managing and supporting vendors on engineering and quality projects for components and sub-assemblies for Class II products in a high variety electro-mechanical Medical device manufacture, assembly, test and packaging environment.
Responsibilities as Senior Manufacturing Engineer (Projects)
- Taking the lead in Vendor performance management by ensuring that key process indicator (KPI) targets associated with Quality, Service and Cost are delivered and met.
- Taking the lead in troubleshooting complex technical issues with a cross functional team including vendor and in-house support (Supply Chain, Manufacturing and R&D) in a process sustaining or improvement activity.
- Participate in supplier selection process through risk assessment and approval of new vendors for dual source or new component supply.
- Participating in surveillance audits to ensure it is fit for purpose.
- Identification of process improvement opportunities to include: improved quality, increased capacity/service and cost saving.
- Implementation of lean and operational excellence principles (6σ, 5S, TPM)
- Scoping out and project managing such improvement projects with cross a functional team including Supply Chain, Quality, R&D and Manufacturing departments.
- Monitoring and statistically analyzing process data, quality and production yields to support supplier management and validation activity.
- Be prepared to represent documentation in an audit by customers, revenue or regulatory authority.
- Perform other assigned tasks as directed by Supervisor or Head of Function
Requirements as Senior Manufacturing Engineer (Projects):
- Meticulous attention to detail with a methodical and analytical approach with good problem-solving tool skillsets
- Very strong organizational, Project Management and communication skills.
- Knowledge of Design Verification and Process Validations, particularly as it pertains to equipment and manufacturing processes.
- Excellent understanding of ISO 13485 and FDA Design and Development Processes.
- Ability to lead complex problem solving and cost/capacity improvement projects with cross-functional teams.
- Ability to grasp and statistically analyze data to achieve desired outcomes.
- Ability to work effectively as part of a multi-disciplinary team is a key requirement.
- Experienced in dealing with marketing, and regulatory teams.
- Green or black belt certification an advantage.
- Moulding Tooling knowledge a distinct advantage.
- Knowledge of electro-mechanical components and sub-assemblies and related processes an advantage
- Highly motivated self-starter with an innovative mind-set.
- Flexibility to travel to vendor sites to support service and project activities
- 5-8 years’ equivalent experience in a Medical Process Development or Manufacturing Environment
- Minimum of a primary degree in Engineering or Technological Discipline
For further information on this Senior Manufacturing Engineer (Projects) role in Galway please contact Deirdre Finnerty on 086 3073779 / firstname.lastname@example.org
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