Our client, a global leader in medical devices is recruiting for a Manufacturing engineer to develop and implement manufacturing business improvement projects and processes in order to achieve production goals (i.e., quality, delivery, cost, productivity, and safety) for the production Unit. The successful candidate will support teams to make improvements to existing products and manufacturing processes and lead projects independently with minimal supervision.
- Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements
- Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
- Demonstrates proficiency in Project Management (Project Charter, Gantt) tools to maximise project opportunities and to influence and inform key customers and stakeholders.
- Create and utilize Risk Register and System FMEA to identify and remove business and technical risks. Plans, organizes, and conducts all aspects of technical reviews.
- Create E&AS documentation to support new and improved manufacturing processes with validation methods for inspection for verification and process controls.
- Coordinates with the suppliers and external resources needed in developing and implementing new process/product plans.
- Summarises, analyses and draws conclusions from test results leading to effective technical resolution.
- Continually seeks to drive / improvements in process design, layout and operational performance.
- Demonstrates good working knowledge and application of validation techniques and associated regulatory requirements.
- Cultivates a wide range of internal business relationships and begins to develop an external network of resources to facilitate completion of tasks.
- Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
- Demonstrate a primary commitment to patient safety and product quality.
- Understands and comply with all the regulations governing the quality systems.
- Executes the functional deliverables associated with the CAPA, VIP, Strategic Initiative, and Quality Systems.
- Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM’s, Routers, FMEA’s, etc.).
- Oversees development builds associated with the project using special work requests.
- Working as part of a team on Operations projects on a particular product (Drug Eluting Stent), transferred from a sister-site
- Continuous improvement projects, quality improvement, sustaining engineering, managing design/component changes into production
- Support of the drug testing batch release, analysis, test method development, issue investigation, presentation to senior mgmt. weekly (in time)
- Working closely with the Sustaining Engineering and R&D team on weekly meetings and updates of future projects/changes/support needed
Qualifications and Experience:
- HETAC Level 8 in a Technical Discipline (Science, Biomedical, Mechanical, Manufacturing, etc.)
- Minimum 3-5 years’ experience ideally in Medical Device industry or other highly regulated environment
- Compliancy with requirements of the site Environmental, Health and Safety standards and follow procedures and instructions related to these standards.
- Influential team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives
- Can provide guidance to others, technicians, associates.
- Project Management experience would be strongly desirable
For further information on this contracting Manufacturing Engineer role in Galway please contact Caroline Kingston on 0868395531/ firstname.lastname@example.org
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