Manufacturing Engineer CREGG Recruitment is seeking a highly skilled Manufacturing Engineer for a permanent role in Shannon.
The ideal candidate will drive manufacturing process improvements, scale-up production, and ensure regulatory compliance in a medical device or pharmaceutical environment.
This is an excellent opportunity to contribute to the development and implementation of state-of-the-art manufacturing equipment while ensuring the quality and efficiency of operations.
Brief Job Description As a Manufacturing Engineer, you will be responsible for leading the procurement, installation, and commissioning of new manufacturing equipment, optimizing workflows, and ensuring regulatory compliance.
You will collaborate cross-functionally to manage the transition of processes from R&D to production and drive continuous improvements across manufacturing operations.
Qualifications/Skills Sought Bachelors or Masters degree in Mechanical, Biomedical, Manufacturing Engineering, or related field.
Minimum 3-5 years of experience in manufacturing engineering, preferably within the medical device or pharmaceutical industries.
Strong expertise in process validation and equipment qualification in regulated industries.
Experience with manufacturing processes involving powders, particle processing, granulation techniques is highly advantageous.
Knowledge of FDA guidelines and ISO 13485 standards.
Proficiency in lean manufacturing, Six Sigma, and other process improvement methodologies.
Strong technical acumen with the ability to solve complex technical problems.
Excellent communication, organisational, and project management skills.
Roles and Responsibilities Lead the selection, procurement, and installation of new manufacturing equipment to support scale-up and commercial production.
Collaborate with suppliers to qualify new equipment, ensuring compliance with design specifications and regulatory standards.
Support the transition of manufacturing processes from R&D to production.
Conduct pFMEA to identify risks and implement controls to improve manufacturing processes.
Develop and execute equipment qualification protocols (IQ/OQ/PQ) and integrate them into overall process validation.
Troubleshoot complex process issues and develop robust solutions.
Track and report on project activities, identifying risks and implementing contingency plans.
Optimize manufacturing workflows and identify opportunities for process improvements.
Provide mentorship to junior engineers and technicians.
Ensure compliance with health, safety, and environmental regulations.
Ensure compliance with medical device regulations, including FDA and ISO 13485.
Contact Information For a confidential discussion about this opportunity, please contact Brendan at or email Skills: Manufacturing Med Device Biomedical R&D Mechanical ISO13485
Six Sigma Benefits:
Mobile phone Paid Holidays Canteen Parking VHI Pension Educational assistance