Job title: Product Development Engineer
Location: Galway,
This is an hourly contract role of 12 months duration.

This position supports the Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector with my client. In this role, you 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.


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.


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)


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.


Does this sound like your next career move? For more info forward your application or contact me on 087 0612325 OR thomas.gallagher@lifescience.ie