Senior Process Development Engineer

Sterling Engineering Ltd - Ireland & Europe; Connacht; On-site; EUR 70,000 - 110,000; Full time

Job summary

Sterling Engineering Ltd - Ireland & Europe seeks a Senior Process Development Engineer to develop, validate, and optimise scalable manufacturing processes for medical devices. You will collaborate with engineering and production teams to drive process improvements and ensure regulatory compliance.

Responsibilities include leading automation efforts, applying Lean Six Sigma, DOE, and statistical methods, and delivering technical reports and CAPA support to maintain quality and efficiency in

Qualifications

• 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 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 CAD software such as AutoCAD or SolidWorks.

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 vision systems, robotics, and digital monitoring.
• Apply Lean methodologies (DMAIC, Kaizen, VSM) for continuous improvement.
• Address process, material, equipment, and quality issues with structured problem solving.
• Develop and maintain manufacturing procedures, work instructions, and docs.
• Conduct process analysis and identify productivity and reliability gains.
• Prepare technical reports and validation protocols.

Skills

Process development

Automation

Lean Six Sigma

DOE

Statistical methods

Project ownership

Regulatory compliance

Communication skills

Education

Engineering degree (Level 8)

Tools

AutoCAD

SolidWorks

Job description

Senior Process Development Engineer

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.