Senior Process Engineer

CREGG; Galway; On-site; EUR 80,000 - 110,000; Full time

Job summary

CREGG is seeking a Senior Process Development Engineer for our Galway medical device manufacturing client. The role leads key development projects, designing, developing, and validating robust processes to ensure safe, compliant production.

The successful candidate will collaborate with cross-functional teams, apply Lean and Six Sigma to drive improvements, and oversee automation initiatives from concept to implementation in a regulated environment.

Qualifications

• Bachelor's degree in Engineering or related field.
• 5+ years of experience in medical device process development.
• Experience in manufacturing, project/program management.
• Knowledge of ISO 13485 and FDA regulatory requirements.
• Proficient in DOE and Six Sigma methodologies.

Responsibilities

• Lead development projects to design, develop, and validate scalable manufacturing processes for medical devices.
• Collaborate with engineering and production teams to optimize manufacturing systems and strategies.
• Drive automation initiatives while ensuring regulatory compliance and quality.
• Identify process improvements using Lean methodologies and CAPA management.
• Develop and validate experiments and documentation, including work instructions and protocols.
• Evaluate new technologies for performance, cost, and reliability.

Skills

Project leadership

Cross-functional collaboration

DOE / Six Sigma

Regulatory knowledge ISO13485 / FDA

Manufacturing process development

Education

Bachelor's degree in Engineering

Tools

DOE Software

Statistical analysis (Minitab)

Job description

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).