Process Development Engineer

Mason Alexander; Galway; On-site; EUR 42,000 - 55,000; Full time

Job summary

Mason Alexander represents a medical device company in Galway seeking a Process Development Engineer to advance catheter-based manufacturing and assembly processes on site.

You will own NPI activities, fixture/equipment design, process validation, and documentation development, collaborating with internal teams and CMOs to deliver compliant, data-driven improvements. The role supports clinical-stage device development and requires rigorous quality practices.

Qualifications

• Bachelor's degree in engineering discipline.
• Minimum 4 years in a medical device process development role, catheter-based products preferred.
• NPI experience including fixtures & equipment design and process validation.

Responsibilities

• Develops manufacturing processes, materials, and methods.
• Designs, specifies, procures and qualifies process fixtures and equipment.
• Develops Work Instructions and other supporting documentation (e.g. calibration and maintenance documents) for manufacturing processes.
• Executes process characterisation and validation activities.
• Development of pFMEA and risk documentation associated with the device and its manufacture.
• Builds Quality into all aspects of work by maintaining compliance to all quality requirements.
• Works with internal cross-functional teams and contract manufacturers.
• Executes project plans, tasks and deliverables. Manages time to meet project deadlines.
• Uses structured problem-solving techniques and statistical methods for data driven analysis and decisions.

Skills

Process development

NPI experience

Statistical methods

Project management

Cross-functional teamwork

Education

Bachelor's Degree in Engineering

Tools

Fixtures design

Process validation

Documentation development

Job description

A new Process Development Engineer role has just opened with a medical device company based on the east side of Galway city.

It is an exciting time to join this company as an engineer as you would be working on a catheter based product that is currently going through its clinical phase. You would be responsible for developing the manufacturing & assembly processes for on site and with suppliers & CMOs.

The company is seeking a passionate experienced engineer to join a small team and take ownership of new product introduction activities such as fixtures, equipment, process and documentation development for this new implantable device.

Responsibilities:

• Develops manufacturing processes, materials, and methods.
• Designs, specifies, procures and qualifies process fixtures and equipment.
• Develops Work Instructions and other supporting documentation (e.g. calibration and maintenance documents) for manufacturing processes.
• Executes process characterisation and validation activities.
• Development of pFMEA and risk documentation associated with the device and its manufacture.
• Builds Quality into all aspects of work by maintaining compliance to all quality requirements.
• Works with internal cross-functional teams and contract manufacturers.
• Executes project plans, tasks and deliverables. Manages time to meet project deadlines.
• Uses structured problem-solving techniques and statistical methods for data driven analysis and decisions.

Experience requirements:

• Bachelors Degree in engineering discipline such as mechanical, bio-mechanical, polymer or related.
• 4 years of experience in a similar role in the medical device industry, with strong process development experience, working with catheter based products.
• NPI experience such as fixtures & equipment design & specification, process validation, and related documentation development.
• Catheter based process experience such as dip coating and spraying is an advantage.

It is a permanent role, based on site, salary up to 55K.