Senior Manufacting Engineer

Senior Manufacturing Engineer (Remote)

Our client a US based startup medical device company who have established a technical operations group in Ireland are currently seeking a Senior Manufacturing Engineer to join their team. Reporting to VP of Technical Operations the Senior Manufacturing Engineer is responsible for leading Manufacturing Engineering activities including activities at contract manufacturing suppliers and distribution centres. The role is primarily remote but will require travel as required to main contract manufacturer which is based in West of Ireland

Role / Responsibilities :

• Directly manage Manufacturing & Project activity at contract manufacturing organizations, including product builds, product quality issue resolution, process development, technical training, validation, and continuous monitoring of manufacturing performance
• Technical leadership of the manufacturing transfer of new products and changes to existing products, supporting the successful transition to manufacturing using design for manufacturability concepts, as applicable.
• Develop and Implement manufacturing capabilities using LEAN principles and tools including but not limited to Value Stream Mapping, Poka-Yoke, Standard Work, Bottleneck Analysis and Line Balance
• Responsible for working with Quality including management of NCMR’s and CAPA’s, supplier monitoring and audits, risk management and internal controls while ensuring compliance with ISO 13485 and other relevant standards and regulations pertaining to medical device and pharmaceutical products.
• Contribute to the successful execution of departmental and company goals.
• Regularly update and recommend to stakeholders the status of objectives, projects, and goals, particularly how they relate to cross-functional business objectives.
• Support business partners by providing technical leadership for company’s long-term manufacturing and distribution channels.
• Development and execution of commercial manufacturing timelines consistent with project and regulatory needs;
• Financial modelling for COGS and scaling up production capacity.
• Technology transfer to partner or contract manufacturing organizations, as applicable
• Promote and support a continuous improvement culture and drives cost saving initiatives.
• Create and manage annual budget for Manufacturing project activities.
• Provide strong integrity, vision, knowledge, and overall aptitude to the organization.

Skills / Experience :

For further information please contact James Cassidy or call in confidence 086 0204322