Senior Process Development Engineer

CREGG; Galway; On-site; EUR 85,000 - 110,000; Full time

Benefits offered by this job

Full benefits package

Job summary

CREGG in Galway, Ireland, is seeking a Senior Process Development Engineer to design, develop, and validate robust manufacturing processes for medical devices. You will lead key development projects and provide direct line support to operations, collaborating closely with production teams to troubleshoot issues and maintain day-to-day performance.

The role requires a Level 8 Engineering degree with 5+ years in medical device process development, and experience with Lean six sigma methods, risk

Qualifications

• 5+ years of relevant experience in medical device process development/manufacturing.
• ISO 13485 and FDA regulatory requirements knowledge.
• Excellent organizational and interpersonal skills.
• Strong risk analysis and process validation experience (equipment/manufacturing).
• Lean tools such as DMAIC, Kaizen, VSM.

Responsibilities

• Collaborate with engineers and production teams to develop and improve manufacturing processes.
• Lead automation initiatives from concept through implementation with regulatory compliance.
• Identify and drive process improvements using Lean methodologies.
• Develop and maintain SOPs and documentation for manufacturing operations.
• Provide line support to manufacturing, troubleshoot issues, and stabilize processes.

Skills

Lean principles

DMAIC

Kaizen

Six Sigma

Problem-solving

Project management

Communication skills

Education

Level 8 degree in Engineering

Tools

AutoCAD

SolidWorks

Job description

Senior Process Development Engineer - Galway

Permanent role with full benefits package.

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

The Senior Process Development Engineer will be responsible for designing, developing, 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 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.
• 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.

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