Process Development Engineer

About Your New Employer

• Join an innovative start-up medical device company developing a next-generation device in Galway.
• Work with an enthusiastic, multidisciplinary team based with the opportunity to contribute to a high-impact start-up environment.

About Your New Job

As a Process Development Engineer, you will support the development, optimisation and implementation of manufacturing and assembly processes for innovative medical devices.

You will:

• Develop manufacturing processes, materials and methods for medical devices, working with internal teams and external development and manufacturing partners.
• Design, specify, procure and qualify process fixtures, tooling and equipment.
• Develop work instructions and supporting manufacturing documentation, including calibration and maintenance requirements.
• Plan and execute process characterisation, verification and validation activities.
• Develop process FMEAs and other risk management documentation relating to product manufacture.
• Collaborate closely with engineering, product development, Quality, suppliers and contract manufacturing partners.
• Apply structured problem-solving techniques and statistical methods to support data-driven manufacturing decisions.
• Manage project activities, deliverables and timelines to ensure successful execution.
• Maintain compliance with applicable quality and regulatory requirements, ensuring quality is embedded throughout the manufacturing process.

What Skills You Need

• A primary or Master’s degree in polymer, mechanical, manufacturing, biomedical engineering or a related discipline.
• At least three years’ experience in medical device development or manufacturing.
• Experience in the development and manufacture of minimally invasive or catheter-based medical devices.
• Demonstrable new product introduction experience within the medical device industry, including:
  • Fixture and equipment design and specification.
  • Process and equipment validation.
  • Development of manufacturing work instructions.
  • Establishment of calibration and maintenance activities.
• Working knowledge of materials and manufacturing processes used in minimally invasive medical devices.
• Experience working within an ISO 13485-compliant manufacturing environment.
• Knowledge of risk management tools, including process FMEA.
• Ability to use statistical techniques, Six Sigma principles and data analysis tools to support manufacturing processes.
• Excellent written and verbal communication skills.
• Strong planning, organisation and project execution skills.
• A collaborative, self-directed and solutions-focused approach.

Experience with complex catheter-based products, delivery systems or other minimally invasive medical technologies would be advantageous. Proficiency in 3D CAD modelling would also be beneficial.

What’s Next

If this opportunity interests you, please submit your application with an up-to-date CV. We also encourage applications from candidates who meet most, but not necessarily all, of the listed requirements and are excited by the opportunity to contribute to an innovative start-up environment.