The Senior Engineer will lead and build the Process Development Team. The successful candidate will define the strategy and direction for the team as well as translate into action the selection, generation and validation of new and existing process technologies. They will support product development team through design and delivery of robust process solutions.
THE ROLE ……
- Build and Manage the R&D team responsible for Process and Equipment development activity.
- Provide technical direction to team, critically analysing and distilling applicable corporate and local site priorities into clear goals & objectives for all team members.
- Define strategy, scope and execution plan for the Process Development activity on site in Galway to ensure robust designs and successful operations transfer.
- Liaise with Project Leaders, R&D & Operations Teams and other internal customers to clearly understand requirements and inputs.
- Develop "advance pilot capability" for key technologies and processes to facilitate efficient and robust process selection and expedited product development cycles.
- Investigate, select and develop appropriate materials, vendors, technologies and specifications to ensure that process solutions are robust and reproducible, in compliance with legal requirements/directives and capable of meeting all qualification requirements.
- Ensure that Design for Manufacturability, safety, capacity, scalability and product cost impacts are considered in all decision making such that design can be transferred seamlessly in to manufacturing at required product cost.
- Plan and Lead/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.
- Performs other related duties and tasks as required.
- Degree in Engineering, related technical field or with appropriate demonstrated experience.
- At least 8 years previous related experience.
- Demonstrated ability in analytical problem-solving, 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.
- Demonstrated People/team management skills.
- Formal project management training an advantage.
- Strong interpersonal and organizational skills and the ability to work effectively as a team member and leader