Our client is a global leader in the Medical Devices industry sector. They have undergone significant growth this year, and are seeking an experienced Process Development Engineer II to join the Process Development Department at their state-of-the-art facility in Galway.
Duties and responsibilities of the Process Development Engineer II will include:
- As an engineer, you will actively participate in all areas of product transfers including the following: Design, Technology development & advancement, Automation, Vendor management, Cell operating System (COS) & Project management.
- You will support all activities related to equipment development and validation to meet internal and regulatory (CE) requirements.
- You will support process development, characterization and validation activities.
- You will use Design, Reliability & Manufacturability methodology (DRM), 3-D drawing/printing and Augmented reality to develop best in class technologies for the manufacture of our medical device product ranges.
- You will collaborate with cross functional teams to define, execute and deliver on program deliverables.
- You will utilize your new and existing skillsets in six sigma tools, project management and technology development to solve technical problems.
- You will compile, document and present all learnings to project and functional teams.
You will have skills and experience in the following:
- Third Level 8 Degree or higher in Electronic, Electrical, Mechanical or Biomedical Engineering or related discipline
- 5+ years relevant industry experience in a similar role
- Knowledge of medical device processes with a good understanding of product and process design
- Develops technical / Equipment documentation including Equipment binders, Equipment validations and technical reports in accordance with quality system requirements
- Support the development and sourcing of vendors, Co-ordinate and liaise with vendors to ensure equipment is sourced to budget and on time
- Supports verification, validation, and implementation of equipment for both design and process development
- Utilizes knowledge of FDA and ISO / CE / EH&S requirements related to equipment / process development, ensuring robust validation and qualification
- Dynamic team player and can work effectively and proactively on cross-functional teams
- Good organizational, presentation and project management skills are desirable
To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.