Process Development Engineer
The Company, is recruiting for a Process  Development Engineer located in Galway, Ireland.

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.
• Monitor supplier performance and provide technical support to resolve issues.
• Assess new and existing suppliers for technical and manufacturing capabilities.
• Identify process improvements (design for manufacture/design for assembly) related to sub-assembly or component usage or design.
• Assess critical to quality requirements for components used to build complex acute ischemic stroke devices and translate these requirements into component specifications that ensure components are manufacturable and performance is maintained consistently.
• Implement changes under the Company change management system. Qualifications
• Mechanical or Biomedical Engineering degree or equivalent.
• A minimum of 4 years’ experience in medical device design and development (including design with SolidWorks, prototyping, testing)
• Data review and statistical methods skills (Minitab)
• High level of technical writing and reporting skills.
• Strong work ethic, creative problem solving, capable of working on own initiative.

Experience

• 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)
• Understanding of product lifecycle and validation requirements for a new product introduction.
• Experience in using a structured problem solving approach is highly desirable. (e.g green belt, DEMAIC)
• Experience in managing technical relationships with external suppliers and OEM is preferred.
• Excellent communication / interpersonal skills required.
• Ability to multi-task, working on multiple projects simultaneously.
• This position is in Galway, Ireland