Manufacturing Engineer

4 weeks ago

Nenagh, Ireland Pale Blue Dot Recruitment Full time

- Engineering ( Production/Process Dev/Manufacturing)

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:

1. Lead the selection, procurement, installation, and commissioning of new manufacturing equipment & utilities to support scale-up and commercialization efforts.
2. Collaborate with suppliers to evaluate and qualify new equipment, ensuring compliance with design specifications and regulatory standards.
3. Train team members on the operation and maintenance of newly introduced equipment.
4. Support manufacturing onsite and at subcontractors/suppliers to ensure that the product quality, regulatory & business requirements are met.
5. 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.
6. Lead the transition/design transfer of manufacturing processes from R&D to production, ensuring scalability and cost-effectiveness.
7. Lead the development and execution of pFMEAs to identify potential failure modes, assess risks, and implement effective controls for manufacturing processes.
8. Optimize manufacturing workflows and identify opportunities for efficiency improvements.
9. 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.
10. Act as a subject matter expert (SME) in manufacturing technologies, troubleshooting complex process issues, and implementing robust solutions.
11. 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.
12. Collaborate with key suppliers and their production/manufacturing teams to drive and support process/product improvements/developments.
13. Ensure all health, safety and environmental requirements are met.
14. Ensure compliance with medical device regulatory requirements, including FDA and ISO 13485 standards.
15. Provide guidance and mentorship to junior engineers and technicians, fostering a culture of continuous learning and professional growth.
16. Perform other related duties as assigned by their supervisor.

Job requirements

Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related field.

A minimum of 3-5 years of experience in manufacturing engineering, preferably in the medical device or pharmaceutical industries.

Strong expertise in process validation and equipment qualification in regulated industries.

Qualifications and education with specialized knowledge of manufacturing with powders, particle processing, and granulation techniques, including safety, quality control, and process optimization, is highly advantageous.

Knowledge and interpretation of FDA guidelines and ISO 13485 requirements with working knowledge of international standards as applicable.

Proficient in lean manufacturing, Six Sigma, and other process improvement methodologies.

Ability to manage multiple projects and prioritize workload effectively to meet project deadlines.

Excellent communication, interpersonal and presentation skills.

Strong technical acumen and ability to understand complex technical concepts/issues and develop practical solutions.

Strong attention to detail and ability to work meticulously to ensure accuracy in testing and documentation.

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