Process Development Engineer II
Mason Alexander New ·www.masonalexander.ie
Apply directA 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.