CroíValve are looking for a Manufacturing Engineer to support the product development of a cutting-edge structural heart device through design development, verification, clinical trials, validation and regulatory approvals. This role is based full time in our Dublin office
Key Responsibilities and Duties
* Co-ordinate day to day production management to meet company build plan objectives.
* Develop manufacturing processes and provide training to technicians and process operators.
* Source and implement tooling, instruments and technologies, as required to implement the manufacture of the device.
* Develop specifications, process development, training, production instructions, material specifications and procurement.
* Develop and update documentation relating to equipment or processes to manufacture the device in a controlled manner in line with Regulatory standards, e.g. specifications, BOM, DHR, DMR, validation documents, etc.
* Develop and execute DOEs to characterize impact of process parameters on manufacture.
* Work with contract manufacturers to implement appropriate production / assembly processes and layouts for manufacture of subassemblies.
* Support quality related activities for device manufacturing, ensuring controls are implemented and maintained (inspection standards, plans, frequencies and test methods, CAPA and NCR resolutions).
* Support product builds to ensure product is manufactured in line with specifications
* Plan daily activities of operators to achieve production to demand plan. This includes supervision and adjustment to daily / weekly production plans to remain on-track.
* Support identification and implementation of process improvements (yield, capacity, efficiencies).
* Develop a thorough "hands-on" understanding of manufacturing procedures, processes and equipment.
* Ensure that a high standard of compliance with GMP is maintained in the manufacturing areas.
* Understanding of EHS rules and requirements and drives identification and implementation of adequate control measures.
Education and Experience
* B.S. or masters degree in mechanical engineering, biomedical engineering, or related disciplines
* 0-1 years experience in medical devices
* Excellent communication, organizational and time management skills
* Experience of preparing technical documentation
The above role profile is not designed to cover a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned from time to time.