Our Client, A leading Medical Device Company based in Galway City, are hiring for a Manufacturing Engineer.
- 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 2 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
- Production / line support experience within a medical device environment.
- Experience of technology transfer and process optimisation.
- Specific experience of laser cutting/welding & adhesive bonding
For more information please call Patrick Brady on 091-507516 or please send a copy of your most updated CV to firstname.lastname@example.org.