I am partnering with one of the most established and well known Medical Devices companies to find engineering leaders for their new team located in Cork. The Equipment / Project Engineer will contribute throughout the Automated Equipment Life Cycle - through development phase / specification phase / design phase / construction phase & qualification phase
1. Participate in a cross functional project team to establish to support the development and introduction of the new automated production equipment.
2. Contribute to the specification of the equipment. Work in conjunction with the Process Engineer to develop appropriate URS documents for each larger element of the line.
3. Support the validation engineer in the development of the Functional Specifications, Trace Matrix.
4. Drive design reviews and build inspections with Equipment vendors.
5. Drive regular status review meetings with vendors.
6. Develop and maintain project timeline for various pieces of equipment.
7. Set-up vendor FAT and support the validation engineer in preparing and executing FAT / SAT protocols.
8. There will be a requirement to travel to Equipment Manufacturer in Europe for short trips as part of this project (for design reviews/ build inspections / FAT execution).
9. Lead the installation phase of the equipment.
10. Support the validation engineer in preparing and executing Equipment IQ & OQ Protocols and the preparation of associated reports.
11. Work in conjunction with the Process/Manufacturing Engineer to prepare for and execute Process OQ/PQ protocols.
KEY SKILLS & EXPERIENCE
- We are looking for a qualified person to Level 8 Degree in Engineering / Science or related discipline, Masters preferred and desirably with 10 years relevant direct engineering experience within medical device environment.
- A minimum of three to five years experience of engineers and a career history of demonstrated progressive research and development experience.
- Dynamic team player and leader and can work effectively and proactively on cross-functional teams.
- Experienced in a medical device market and have a proven result driven track record.
- Excellent team building, communication, people management and leadership skills are desirable.
- MUST BE AN EU CITIZEN OR HAVE CURRENT WORK RIGHTS FOR IRELAND
If you are interested - please apply now or contact Lisa Jessup - Principal Consultant on firstname.lastname@example.org or 0871139735