Manufacturing Process Leader

2 days ago


Limerick, Limerick, Ireland Pale Blue Dot Recruitment Full time

Job Description:


A leading Medical Device company, based in the region, is seeking a highly skilled Manufacturing Engineer to join their team. The ideal candidate will play a pivotal role in scaling up manufacturing processes from development to commercial production.


The selected individual will lead the procurement, qualification, and integration of manufacturing equipment while ensuring regulatory compliance and operational efficiency. They will drive technical excellence in manufacturing operations, enabling high-quality production at scale, and collaborate cross-functionally to achieve project milestones.


Main Responsibilities:

  • 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.
  • Optimize manufacturing workflows and identify opportunities for efficiency improvements.
  • Support timely introduction of 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.
  • Cultivate strong relationships 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.
  • Comply 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.
  • Maintain accurate records of process documentation and supporting evidence.
  • Perform other related duties as assigned by their supervisor.


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