Medical Device Process Development Engineer – NPI & Validation

ICS Medical Devices; Galway; On-site; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Private medical insurance

Additional Holidays

Sick pay

Occupational Pension Plan

Sports Social Club

Cycle to Work Taxsaver Commuter Ticket

Job summary

ICS Medical Devices is seeking a Process Development Engineer in Ireland to support the development, validation, and optimisation of manufacturing processes for medical device products. This role offers a path to influence product quality within a regulated environment.

The successful candidate will lead scale-up, plan IQ/OQ/PQ validation, and maintain rigorous process documentation, collaborating with cross-functional teams to deliver robust production capabilities.

Qualifications

• Bachelor’s degree in Mechanical Engineering or Biomedical Engineering.
• 3+ years in process development within the medical device industry.
• Experience scaling manufacturing processes in regulated environments.
• Hands-on IQ/OQ/PQ validation experience.
• Strong documentation and communication skills.

Responsibilities

• Lead the development, optimisation, and scale-up of manufacturing processes for new product introductions (NPI).
• Plan and execute IQ/OQ/PQ validation activities in line with FDA, ISO 13485, MDR, and internal requirements.
• Prepare and maintain process documentation, including SOPs, work instructions, PFMEAs, and control plans.
• Conduct process capability studies and apply statistical tools such as SPC and DOE.
• Identify and implement process improvements to enhance product quality, efficiency, and yield.
• Troubleshoot process-related issues and support effective CAPA activities.
• Collaborate with cross-functional teams on product transfers and scale-up initiatives.
• Contribute to risk management activities in alignment with ISO 14971.
• Maintain compliance with GMP, Health & Safety, and the internal Quality Management System.

Skills

Mechanical Engineering

Biomedical Engineering

Process development

IQ/OQ/PQ validation

SPC and DOE

Lean Six Sigma

Regulatory knowledge (ISO 13485, FDA c

Education

Bachelor’s degree in Mechanical Engineering

Bachelor’s degree in Biomedical Engineering

Job description

ICS Medical Devices is seeking a Process Development Engineer in Ireland to support the development, validation, and optimisation of manufacturing processes for medical device products. This role offers a path to influence product quality within a regulated environment.

The successful candidate will lead scale-up, plan IQ/OQ/PQ validation, and maintain rigorous process documentation, collaborating with cross-functional teams to deliver robust production capabilities.