Manufacturing Engineer with equipment and process validation experience required for permanent role with growing medical devices company in Galway
Responsibilities:
- Reporting on yield, OEE metrics and product failure investigation
- Support the introduction of new Products and Process technology through Process development and Validation
- Use Lean methodologies to drive continuous improvement focused on Quality, Cost, Material flow and layout
- Lead or actively participate in cross-functional teams to ensure that continuous improvement projects are completed in a timely and efficient manner
- Preparation and maintenance of manufacturing specifications for specific projects
- Ensure effective closure on Quality System documents (Audit Actions, NC’s, CAPA’s, etc)
- Ensure all production equipment, processes and work areas meet Health & Safety requirements through the completion of the required documentation
- Support all customer, FDA and NSAI audits when required
Requirements:
- Minimum of a primary degree in an engineering or technological discipline
- Minimum of 4 years’ experience
- Knowledge of equipment and process validation
- Ability to manage multiple assignments or projects with sound analytical, troubleshooting, and problem solving skills
- Understanding of ISO 13485 and FDA design and development processes
- Experience with Lean methodologies ideal
- Ability to work as part of a multi-disciplinary team with good interpersonal skills
- Excellent planning and coordination skills and capable of initiating and leading change
- Ability to present ideas and concepts clearly and effectively to all levels of the company
- Proficiency in use of desktop software applications such as MS office
Please contact Emer Smith to discuss in confidence
00353578638188
emer@emtechrecruitment.ie
