Senior Manufacturing Engineer

CREGG; Limerick; On-site; EUR 85,000 - 115,000; Full time

Job summary

CREGG in Limerick is seeking a Senior Manufacturing Engineer to sustain and validate robust processes for medical devices, ensuring safety, effectiveness and regulatory compliance.

You will lead projects, support daily operations, partner with production teams to troubleshoot and stabilize processes, and drive Lean improvements.

The role requires a Level 8 Engineering degree and 5+ years of experience; Green Belt is a plus, with strong problem-solving and quality focus.

Qualifications

• Degree in Engineering at level 8; 5+ years of relevant experience.
• Green Belt certification is a distinct advantage.
• Medical device process development, manufacturing experience.
• Strong risk analysis, problem-solving and process validation skills.
• Team player with proactive ownership of tasks and projects.
• Excellent organizational and interpersonal skills.
• Lean knowledge: DMAIC, Kaizen, Value Stream Mapping.
• ISO 13485 and FDA regulatory requirements knowledge.
• DOE and Six Sigma statistical techniques proficiency.

Responsibilities

• Collaborate with engineers and production teams to improve processes.
• Develop and implement manufacturing systems to meet cost, quality and time objectives while scaling output.
• Lead Sustaining projects from design to implementation with regulatory compliance.
• Identify and drive Lean-based process improvements.
• Apply structured problem-solving to issues and provide manufacturing solutions.
• Maintain operational processes reflecting industry best practices and regulatory requirements.
• Assess automation options to boost productivity and reliability.
• Develop experiments and validation plans; analyze results and report.
• Resolve CAPA, non-conformances and audit observations.
• Create training materials to transfer knowledge to production teams.
• Engage stakeholders to evaluate new technologies for performance and cost.

Skills

Lean principles

Problem-solving

Risk analysis

Statistical methods

Cross-functional teamwork

Process validation

Quality mindset

Education

Level 8 degree in Engineering

Green Belt certification (advantage)

Job description

Senior Manufacturing Engineer - Limerick

Medical Device

Candidates must have full authority to work in Ireland full time.

The Senior Manufacturing Engineer will be responsible for Sustaining and validating robust, scalable processes that ensure our medical devices are produced safely, effectively, and in compliance with all applicable regulations. In addition to leading key development projects, this role will provide direct line support to manufacturing operations, working closely with production teams to troubleshoot issues, stabilize processes, and maintain day-to-day performance.

Duties & Responsibilities

• Collaborate with engineers and production teams to develop and improve manufacturing processes.
• Develop and implement manufacturing systems and strategies to achieve cost, quality, and time objectives while scaling up output to meet required annual growth rates.
• Lead Sustaining project initiatives, from conceptual design through implementation, ensuring seamless integration with existing manufacturing processes and full compliance with quality and regulatory standards
• Identify and drive implementation of process improvements using Lean methodologies.
• Apply structured problem-solving techniques to process, material, or equipment issues, offering manufacturing or quality solutions from experience.
• Develop and maintain operational processes and procedures that reflect industry best practices and comply with relevant regulatory requirements.
• Perform process analysis and identify areas for improvement, including the evaluation and implementation of automation technologies (e.g., vision systems, robotics, digital monitoring) to enhance productivity, efficiency, and process reliability.
• Develop complex experiments and validation protocols; analyse results, make recommendations, and prepare technical reports.
• Analyse and resolve complex manufacturing and compliance issues (e.g., CAPA, non-conformances, audit observations).
• Develop training materials and documentation (e.g., work instructions) to ensure effective knowledge transfer to production teams.
• Work with internal stakeholders to explore and assess new technologies in terms of performance, cost, and reliability.
• Actively engage in and support daily manufacturing operations. support process and equipment validations IQOQPQ execution.

Skills & Experience Required:

• Level 8 degree in Engineering or related discipline, with 5+ years of relevant experience.
• Green Belt certification is a distinct advantage.
• Proven experience in medical device process development, manufacturing, and project/program management.
• Strong skills in risk analysis, problem-solving, and process validation (equipment and manufacturing).
• Dynamic team player with proactive ownership of tasks and projects.
• Excellent organizational and interpersonal skills.
• Solid understanding of Lean principles and tools (e.g., DMAIC, Kaizen, Value Stream Mapping).
• In-depth knowledge of ISO 13485 and FDA regulatory requirements.
• Proficiency in statistical techniques (e.g., DOE, Six Sigma).