Process Development Engineer – Cork
- Cork City
PE Global is currently recruiting for a Process Development Engineer for a leading multi-national Med Device client based in Cork.
This is an initial 12-month contract position.
- Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on platform or derivative projects.
- Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
- Executes the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.
- Plans, organizes, and conducts all aspects of technical reviews.
- Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM’s, Routers, FMEA’s, etc.).
- Writes and reviews validation protocols and reports applicable to new processes.
- Oversees development builds associated with the project using special work requests.
- Develops qualified production lines.
- Provides Design for Manufacturability (DFM) input to the engineering print package.
- Contributes ideas to or generates Intellectual Property submissions.
- Trains and/or provides work direction to technicians and engineers and may train manufacturing personnel when required as part of a validation.
- May serve as a core team member or extended team member on new product projects.
- Bachelor’s degree or higher in Mechanical or a related Engineering field is required
- 3-5 years’ proven experience in NPI for medical devices
- Experience developing processes through risk and validation streams.
- Experience with ISO requirements and GMP guidelines, FDA regulations, medical device design control, and manufacturing scale up processes
- Experience participating in multi-functional teams and NPD design transfer to manufacturing
Interested candidates should submit an updated CV.
Please click the link below to apply, call Seán on +353 21 4297900 or alternatively send an up to date CV to email@example.com
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***