Process Development Engineer

ICS Medical Devices; Galway; In loco; EUR 65.000 - 90.000; Tempo pieno

Vantaggi offerti da questo lavoro

Private medical insurance

Additional Holidays

Sick pay

Occupational Pension Plan

Sports Social Club

Cycle to Work Taxsaver Commuter Ticket

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Mechanical Engineering

Biomedical Engineering

Process development

IQ/OQ/PQ validation

SPC and DOE

Lean Six Sigma

Regulatory knowledge (ISO 13485, FDA c

Formazione

Bachelor’s degree in Mechanical Engineering

Bachelor’s degree in Biomedical Engineering

Descrizione del lavoro

ICS Medical Devices | Full‑time, Permanent

ICS Medical Devices is growing, and we are seeking a Process Development Engineer to support the development, validation, and optimisation of manufacturing processes for new and existing medical device products. This role is ideal for someone who enjoys contributing to innovation, applying structured problem‑solving, and collaborating to deliver high‑quality outcomes within a regulated environment.

Essential Duties 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

Required Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field
• 3+ years of experience in process development within the medical device industry
• Experience developing and scaling manufacturing processes in a regulated environment
• Hands‑on experience with process validation (IQ/OQ/PQ)
• Strong technical and analytical capabilities
• Knowledge of Lean, Six Sigma, and continuous improvement methodologies
• Understanding of regulatory standards such as ISO 13485, FDA cGMP, and MDR
• Strong communication skills and attention to detail in technical documentation

Preferred

• Lean Six Sigma certification (Green Belt, Black Belt, or equivalent)
• Experience with Design for Manufacturability (DFM) and Design for Assembly (DFA)

Benefits

• Competitive Salary Bonus
• Private medical insurance
• Additional Holidays
• Sick pay
• Occupational Pension Plan
• Sports Social Club
• Cycle to Work Taxsaver Commuter Ticket Scheme