Senior Process Engineer

CREGG; Galway; On-site; EUR 75,000 - 105,000; Full time

Job summary

CREGG in Galway seeks a Senior Process Development Engineer for a permanent role to lead key development projects and design, develop, and validate robust, scalable processes ensuring safe and compliant medical device production.

The candidate will collaborate with engineers and production teams, drive automation initiatives, and apply Lean methodologies to improve cost, quality, and throughput. Strong regulatory knowledge and DOEs expected.

Qualifications

• 5+ years of relevant experience in engineering.
• Proven experience in medical device process development and manufacturing.
• Knowledge of ISO 13485 and FDA regulatory requirements.
• Excellent organizational and interpersonal skills.
• Proficiency in statistical techniques (DOE, Six Sigma).

Responsibilities

• Collaborate with engineers and production teams to develop manufacturing processes.
• Lead automation initiatives and integrate with existing processes.
• Identify process improvements using Lean methodologies.
• Develop validation protocols and technical reports.
• Address CAPA and audit observations.
• Prepare training materials for production teams.

Skills

Process development

Project management

Six Sigma

DOE

Team player

Education

Level 8 Engineering degree

Tools

AutoCAD

SolidWorks

Job description

Senior Process Development Engineer

Our Galway based medical device manufacturing client has a permanent role available for a Senior Process Development Engineer. The successful candidate will lead key development projects and be responsible for designing, developing, and validating robust, scalable processes that ensure medical devices are produced safely, effectively, and in compliance with all applicable regulations.

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.

Skills & Experience Required:

• Level 8 degree in Engineering or related discipline, with 5+ years of relevant experience.
• Proven experience in medical device process development, manufacturing, and project/program management.
• Dynamic team player with proactive ownership of tasks and projects.
• Excellent organizational and interpersonal skills.
• 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).