LSC have a great Opportunity for a Senior Process Engineer to join a large Medical Device company in Galway.
In this role, the candidate will be responsible for developing and delivering complex acute ischemic stroke projects with significant technical challenges. Responsible for various aspects of the projects, including process development, design development support through the product development lifecycle, implementation of new equipment/automation and new product introduction.
Emphasis will be on delivering projects on-time, within budget in a compliant and reliable manner. You will be required to support the building of project plans, aligning partners, managing the timeline, budget and driving team accountabilities to deliver the final project objectives.
Key Responsibilities
- Work collaboratively with cross-functional project teams to develop robust product design to ensure capable manufacturing processes.
- Build and Assess device prototypes to support characterization.
- Work on manufacturing line/pilot line with external suppliers to characterize and validate new and improved manufacturing processes and components.
- Work with suppliers and incoming inspection laboratories to develop, validate and ensure appropriate inspection methods and controls are in place for components and finished devices.
- Identify project risks and develop mitigation strategies to ensure supply, quality and timelines are met.
- Identify process improvements (design for manufacture/design for assembly) related to sub-assembly or component usage or design.
Qualifications & Experience
- A minimum of 4 years' experience in medical device design and development (including design with SolidWorks, prototyping, testing)
- Prior experience in medical device catheter process design and or manufacturing is highly desirable.
- Experienced in executing validation of equipment or processes, including preparation of protocols and reports. (OQ/PQ)
