Process Development Engineer II - Medical Device Catheters

Mason Alexander; Galway; On-site; EUR 50,000 - 61,000; Full time

Job summary

Mason Alexander is assisting a Galway-based medical device company in sourcing a Process Development Engineer to develop manufacturing and assembly processes for a catheter-based implant going through clinical trials.

The role involves ownership of process development, fixtures and equipment, work instructions, and documentation in collaboration with suppliers and CMOs, with a focus on quality and on-time delivery.

Qualifications

• Bachelor's degree in engineering (mechanical, bio-mechanical, polymer or related).
• 4+ years in a similar medical device role with process development experience.
• Experience with NPIs, fixtures/equipment design & documentation.
• Catheter-based process experience such as dip coating and spraying is an advantage.
• SolidWorks proficiency.

Responsibilities

• Develops manufacturing processes, materials, and methods.
• Designs, specifies, procures and qualifies process fixtures and equipment.
• Develops Work Instructions and calibration/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 quality requirements.
• Works with internal cross-functional teams and contract manufacturers.
• Executes project plans, tasks and deliverables; manages time to meet deadlines.
• Uses structured problem-solving techniques and statistical methods for data-driven decisions.

Skills

Process development

Statistical methods

Problem solving

Cross-functional collaboration

Education

Bachelor's degree in engineering

Tools

SolidWorks

Job description

Mason Alexander is assisting a Galway-based medical device company in sourcing a Process Development Engineer to develop manufacturing and assembly processes for a catheter-based implant going through clinical trials.

The role involves ownership of process development, fixtures and equipment, work instructions, and documentation in collaboration with suppliers and CMOs, with a focus on quality and on-time delivery.