Senior Process Development Engineer

Mason Alexander; Galway; On-site; EUR 60,000 - 80,000; Full time

Benefits offered by this job

Competitive salary

Career progression opportunities

Supportive engineering environment

Job summary

Mason Alexander is seeking a Senior Process Development Engineer in Galway, Ireland. This role involves designing, developing, and optimizing manufacturing processes for medical devices, ensuring compliance with industry regulations.

The ideal candidate will have a strong background in process development, with at least 5 years of experience, and a solid understanding of regulatory requirements. A competitive salary and benefits package is offered along with opportunities for career progression.

Qualifications

• Minimum 5 years' experience in process development or manufacturing engineering.
• Strong understanding of ISO 13485 and FDA regulations.
• Experience with Lean Manufacturing and continuous improvement methodologies.

Responsibilities

• Develop, optimize, and validate manufacturing processes for medical devices.
• Collaborate with engineering and production to improve efficiency.
• Lead automation projects and drive continuous improvement initiatives.

Skills

Process validation

Lean Manufacturing

Six Sigma

Problem-solving

Stakeholder management

Education

Degree in Engineering or related discipline

Tools

AutoCAD

SolidWorks

Job description

An innovative and expanding medical device company, is seeking a Senior Process Development Engineer to play a pivotal role in the development, optimisation, and scale-up of manufacturing processes. This position offers the opportunity to lead strategic process improvement and automation projects while providing hands-on support to manufacturing operations in a highly regulated environment.

As a Senior Process Development Engineer, you will be responsible for designing, developing, validating, and continuously improving manufacturing processes that ensure products are produced safely, efficiently, and in compliance with industry regulations. You will work cross-functionally with engineering, quality, and production teams to support business growth, operational excellence, and product quality.

This is an excellent opportunity for a motivated engineer who enjoys balancing project leadership with practical manufacturing support and problem-solving.

Responsibilities

• Develop, optimise, and validate robust manufacturing processes for medical device products
• Collaborate with engineering and production teams to improve manufacturing efficiency, quality, and scalability
• Lead automation projects from concept through implementation, ensuring successful integration into existing operations
• Drive continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies
• Apply structured problem-solving techniques to resolve process, equipment, and material-related challenges
• Develop and maintain manufacturing procedures, work instructions, and technical documentation
• Design and execute process validation activities, including equipment qualification and manufacturing validation protocol
• Analyse manufacturing data and implement improvements to enhance productivity, process capability, and reliabilitySupport investigations related to CAPAs, non-conformances, deviations, and audit findings
• Evaluate and implement emerging technologies including robotics, vision systems, and digital manufacturing solutions
• Provide technical leadership and day-to-day support to manufacturing operations
• Develop training materials and support knowledge transfer across production teams

Requirements

• Degree-qualified (Level 8 or equivalent) in Engineering or a related discipline
• Minimum 5 years' experience in process development, manufacturing engineering, or process improvement within the medical device industry
• Proven experience in process validation, manufacturing support, and project delivery
• Strong understanding of medical device regulatory requirements, including ISO 13485 and FDA regulations
• Experience applying Lean Manufacturing principles and continuous improvement methodologies
• Knowledge of statistical tools and techniques including DOE and Six Sigma
• Excellent problem-solving, analytical, and decision-making skills
• Strong communication and stakeholder management abilities
• Experience with engineering design software such as AutoCAD or SolidWorks is advantageous
• Lean Six Sigma Green Belt certification is desirable

What's on offer

• Opportunity to join a growing and innovative medical device organisation
• Exposure to advanced manufacturing and automation technologies
• A highly collaborative and supportive engineering environment
• Career progression opportunities within a rapidly evolving business
• Competitive salary and benefits package