Senior Process Manufacturing Engineer

Cregg Recruitment; Galway; On-site; EUR 75,000 - 97,000; Full time

Job summary

A Galway-based medical device manufacturer is seeking a Senior Process Engineer to lead development projects and provide direct line support to manufacturing operations.

You will troubleshoot issues with production teams, stabilise processes, and implement Lean improvements while driving automation and ensuring compliance with ISO 13485 and FDA requirements.

The role requires a Level 8 engineering degree with 5+ years of relevant experience and a proactive, collaborative approach.

Qualifications

• Engineering degree (Level 8) or related discipline.
• 5+ years of experience in medical device process development.
• Strong knowledge of Lean, Six Sigma and quality systems.
• Experience with ISO 13485 and FDA regulations is preferred.
• Proficiency with AutoCAD/SolidWorks for process layouts.

Responsibilities

• Lead development projects and support manufacturing operations to stabilize processes.
• Collaborate with production teams to scale up output and meet growth targets.
• Drive automation initiatives and ensure compliance with quality/regulatory standards.
• Apply structured problem-solving to CAPA, deviations, and process validation.
• Develop and maintain SOPs and technical documentation for training.

Job description

Job Description

Senior Process Engineer Permanent Senior Process Development Engineer available with our Galway based medical device manufacturing client. 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.

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 automation 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.

Requirements

• 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).
• Competence in engineering design software (e.g., AutoCAD, SolidWorks).

INDTRAC Skills

CAPA Validation Project Management TPBN1_IJ