CroíValve are looking for an NPI 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
0-4 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.
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