Manufacturing Engineer – Contract – Galway
Job ID: JOB-12955
Manufacturing Engineer – 12-month hourly rate contracting
Reports to: Manufacturing Manager
My client is recruiting for a Manufacturing Engineer located in Galway Ireland.
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. The successful candidate with work closely with our regulatory partners to ensure our devices meet all the requirements of EUMDR.
This includes providing technical expertise within the manufacturing engineering team tasked with the production of acute ischemic stroke devices. Activities such as equipment validation, process validation, risk assessments and supporting regulatory and quality documentation at our external manufacturer are core to the role.
The responsibilities and the impact YOU will have:
- Support the introduction of EUMDR certification of the suite of stroke devices in Galway
- 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
- Production / line support experience within a medical device environment.
- Experience of technology transfer and process optimisation.
- Specific experience of laser cutting/welding & adhesive bonding
Please contact Anna McGowan on 0864667369 or email firstname.lastname@example.org to discuss further
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