Process Development Engineer

Mason Alexander; Galway; On-site; EUR 47,000 - 63,000; Full time

Job summary

Mason Alexander is seeking a Process Development Engineer for a medical device company on the east side of Galway city. The role focuses on developing manufacturing and assembly processes for on-site production and with suppliers and CMOs for a catheter-based implantable device.

You will own NPI activities, design fixtures and equipment, develop work instructions and validation plans, and work with cross-functional teams to ensure quality and on-time delivery.

Qualifications

• Bachelor's degree in engineering (mechanical, bio-mechanical, polymer or related).
• Minimum 4 years of experience in a similar role in the medical device industry with strong process development experience for catheter-based products.
• NPI experience including fixtures & equipment design, process validation, and related documentation development.
• Catheter-based process experience such as dip coating and spraying is advantageous.
• SolidWorks experience required.

Responsibilities

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

Skills

Problem solving

Data analysis

Cross-functional teamwork

Education

Bachelor's degree in engineering (mechanical / bio-mechanical / polymer)

Tools

SolidWorks

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.
• Solid Works experience.

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