R & D Process Development Engineer - Medical Devices Galway
A major medical devices manufacturing company in Galway is hiring a Senior Process Development Engineer
Liaise with Project Leaders, R&D & Operations Team members and other internal customers to clearly understand requirements and inputs.
Investigate, select and develop appropriate materials, vendors, technologies and specifications to ensure that process design is robust and reproducible and capable of meeting all qualification requirements.
Ensure that Design for Manufacturability, capacity and product cost impacts are considered in all decision making such that design can be scaled seamlessly in to manufacturing at required product cost.
Define and put in place drawings, BOM's and Routers and procedure to ensure the product design is translated accurately in to Manufacturing.
Plan and execute risk assessment, process specification/ test methods development and subsequent Process Qualifications (IQ,OQ,PQ)
Generate and maintain required Engineering and Design documentation in line with the Quality Management System and associated regulatory requirements.
Provide Guidance to Junior Engineers and Technicians within the R&D Department.
Performs other related duties and tasks as required.
Degree in Engineering or a related technical field
At least 5 years previous related experience.
Demonstrated analytical problem-solving abilities.
Demonstrated ability in Process development, validation and statistical analysis.
Experience in Metal processing & joining techniques and emerging process technologies an advantage.
Good working knowledge of medical device materials and processes.
Working knowledge of Solidworks and / or 3D modeling.
Formal project management training an advantage.
Good working knowledge of Microsoft Office including MS Project or similar.
Strong interpersonal and organizational skills and the ability to work effectively as a team member.
Please send your CV to
or call Christy O'Hara on 087 94 73 404 for more information