Process Development Engineer II

Mason Alexander; Galway; Sur place; EUR 50 000 - 61 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Process development

Statistical methods

Problem solving

Cross-functional collaboration

Formation

Bachelor's degree in engineering

Outils

SolidWorks

Description du poste

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.

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.