Job ID: JOB-12939
MDR/Vigilance Specialist – 12 Month Contract (Hybrid)
We are looking to speak with experienced Manufacturing Engineers about this great new job opportunity in Galway with one of our leading clients. This company stands out for their culture, exceptional career development pathways and unrivalled rewards and recognition packages.
This exciting new job opportunity in Manufacturing Engineering is located Galway. Galway, voted “Europe most Friendliest City 2020”!
Apply to us to find out more about this great job opportunity in Manufacturing Engineering in Galway and we can talk though if it’s the right job for you.
The Manufacturing Engineer works as part of a multi-functional team supporting the implementation of EUMDR registration of medical devices used for the treatment of stroke. This includes providing technical expertise within the manufacturing engineering team tasked with the production of acute ischemic stroke devices.
- Support the introduction of EUMDR certification of the suite of stroke devices
- Completion and review of MPI documentation for all products in line with new regulatory directives
- Establish relationship with external manufacturers ensuring production targets are achieved.
- Completion and review of process risk analysis and ongoing dedication to risk reduction.
- Provide design for manufacture feedback/support to R&D team during new product development phase.
- Support equipment specification, procurement, calibration, and maintenance.
- Collaborate closely with component and service suppliers on any quality issues.
- Applies advanced statistical methods and performs mathematical calculations to resolve manufacturing processes, staff requirements, and production standards.
- Applies verbal and written communications skills in periodic and special reports and presentations both internally and with customers.
- Performs analytical problem solving/process improvement projects and utilizes structured decision making skills.
- Gives technical mentorship to junior engineers/technicians.
- Mechanical or biomedical engineering degree or equivalent.
- Minimum of 4 years’ experience within a GMP regulated Operations Department environment.
- A strategic team-player, with deep-rooted initiative and accountability
- Inherent critical thinking and problem-solving skills
- Working knowledge of six sigma and/or lean engineering principles with a proven track record in use and delivery of results!
- Regulatory /Quality documentation writing experience highly favourable
- Specific experience of laser cutting/welding & adhesive bonding an advantage
For further information on this role in Galway please contact Fiona Barry on 0861287512 or Fiona.firstname.lastname@example.org
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