Senior Process Development Engineer

Sterling Engineering; Galway; On-site; EUR 70,000 - 90,000; Full time

Benefits offered by this job

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Job summary

Sterling Engineering in Galway, Ireland, seeks a Senior Process Development Engineer to develop, validate, and optimise manufacturing processes for medical devices, combining development, support, automation, and regulatory compliance.

You will lead process validation, DMAIC, Lean/Six Sigma, and work with design and manufacturing teams to improve yield, scalability, and reliability, while ensuring ISO 13485 and FDA requirements.

Qualifications

• 8+ years of experience in engineering/manufacturing within medical devices

Responsibilities

• Develop, validate, optimise manufacturing processes for medical device production

Job description

Senior Process Development Engineer Role Overview

Responsible for developing, validating, and improving robust and scalable manufacturing processes for medical device production. The role combines process development, manufacturing support, automation, continuous improvement, troubleshooting, and regulatory compliance.

Key Responsibilities

• Develop, optimise, and validate manufacturing processes to meet quality, cost, efficiency, and production targets.
• Work closely with engineering and production teams to troubleshoot issues and improve process performance.
• Lead automation initiatives, including the implementation of vision systems, robotics, and digital monitoring technologies.
• Drive continuous improvement using Lean methodologies such as DMAIC, Kaizen, and Value Stream Mapping.
• Apply structured problem-solving to process, material, equipment, and quality issues.
• Develop and maintain manufacturing procedures, work instructions, and operational documentation.
• Conduct process analysis and identify opportunities to improve productivity, reliability, and scalability.
• Develop experiments, validation protocols, analyse results, and prepare technical reports.
• Support the investigation and resolution of CAPAs, non-conformances, and audit observations.
• Develop training materials and support knowledge transfer to manufacturing teams.
• Evaluate new technologies based on performance, cost, reliability, and suitability for manufacturing.
• Provide hands‑on support to day‑to‑day manufacturing operations.

Education & Experience Level

• 8 degree in Engineering or a related discipline.
• 5+ years of relevant engineering/manufacturing experience.
• Medical device process development and manufacturing experience.
• Experience with project/program management and process validation.
• Strong knowledge of risk analysis, structured problem-solving, and continuous improvement.
• Understanding of Lean, Six Sigma, DOE, and statistical techniques.
• Knowledge of ISO 13485 and FDA regulatory requirements.
• Experience with engineering/design software such as AutoCAD or SolidWorks.
• Green Belt certification is advantageous.
• Strong communication, organisational, teamwork, and project ownership skills.

Benefits

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