Manufacturing Engineer

Our Client, A leading Medical Device company based in Clare, are seeking a Manufacturing Engineer to join their team. The Manufacturing Engineer will play a pivotal role in scaling up manufacturing processes from development to commercial production, with a focus on new equipment introduction, process optimization, and validation.

This position requires a candidate who can lead the procurement, qualification, and integration of manufacturing equipment while ensuring regulatory compliance and operational efficiency. The ideal candidate will drive technical excellence in manufacturing operations, enabling high-quality production at scale, and collaborate cross functionally to achieve project milestones.

Responsibilities include but are not limited to:

• Lead the selection, procurement, installation, and commissioning of new manufacturing equipment & utilities to support scale-up and commercialization efforts.

• Collaborate with suppliers to evaluate and qualify new equipment, ensuring compliance with design specifications and regulatory standards.

• Train team members on the operation and maintenance of newly introduced equipment.

• Support manufacturing onsite and at subcontractors/suppliers to ensure that the product quality, regulatory & business requirements are met.

• Track and report progress across project activities by reviewing schedules and due dates, identifying risks and implementing contingency plans. Communicate effectively with all internal & external stakeholders.

• Lead the transition/design transfer of manufacturing processes from R&D to production, ensuring scalability and cost-effectiveness.

• Lead the development and execution of pFMEAs to identify potential failure modes, assess risks, and implement effective controls for manufacturing processes.

• Optimize manufacturing workflows and identify opportunities for efficiency improvements.

• Supports timely introduction on any new process upgrades by developing and executing equipment qualification protocols (IQ/OQ/PQ), integrating them into the overall process validation framework.

• Act as a subject matter expert (SME) in manufacturing technologies, troubleshooting complex process issues, and implementing robust solutions.

• Assess and approve process changes ensuring product impact is appropriately considered. Compile any necessary equipment/capital authorization requests supported with appropriate justifications and alternative options.

• Collaborate with key suppliers and their production/ manufacturing teams to drive and support process/product improvements/developments.

• Ensure all health, safety and environmental requirements are met.

• Ensure compliance with medical device regulatory requirements, including FDA and ISO 13485 standards.

• Provide guidance and mentorship to junior engineers and technicians, fostering a culture of continuous learning and professional growth.

• Performs other related duties as assigned by their supervisor.

Lead the selection, procurement, installation, and commissioning of new manufacturing equipment & utilities to support scale-up and commercialization efforts.

Collaborate with suppliers to evaluate and qualify new equipment, ensuring compliance with design specifications and regulatory standards.

Train team members on the operation and maintenance of newly introduced equipment.

Support manufacturing onsite and at subcontractors/suppliers to ensure that the product quality, regulatory & business requirements are met.

Track and report progress across project activities by reviewing schedules and due dates, identifying risks and implementing contingency plans. Communicate effectively with all internal & external stakeholders.

Lead the transition/design transfer of manufacturing processes from R&D to production, ensuring scalability and cost-effectiveness.

Lead the development and execution of pFMEAs to identify potential failure modes, assess risks, and implement effective controls for manufacturing processes.

Optimize manufacturing workflows and identify opportunities for efficiency improvements.

Supports timely introduction on any new process upgrades by developing and executing equipment qualification protocols (IQ/OQ/PQ), integrating them into the overall process validation framework.

Act as a subject matter expert (SME) in manufacturing technologies, troubleshooting complex process issues, and implementing robust solutions.

Assess and approve process changes ensuring product impact is appropriately considered. Compile any necessary equipment/capital authorization requests supported with appropriate justifications and alternative options.

Collaborate with key suppliers and their production/ manufacturing teams to drive and support process/product improvements/developments.

Ensure all health, safety and environmental requirements are met.

Ensure compliance with medical device regulatory requirements, including FDA and ISO 13485 standards.

Provide guidance and mentorship to junior engineers and technicians, fostering a culture of continuous learning and professional growth.

Performs other related duties as assigned by their supervisor.