Job title: R&D Engineer OR Senior R&D Engineer

Location: GMIT, Galway



Company:

My client are a Medical Device company who recently received an award for best indigenous start up. Focused on developing patient solutions in the area of palliative care. Their initial technology platform is a smart catheter-based device used to treat the build up of fluid in the body as a result of late-stage cancers.



Role:

I am looking for an R&D Engineer who will thrive in a multidisciplinary start-up environment. Your curiosity and work ethic sets you apart and you are motivated by the positive influence your work will have on the quality of life of your customers.


As an R&D Engineer working and reporting to the R&D Project Lead, you will get the opportunity to apply your engineering knowledge in areas such as design, test method development and validation, CAD and design controls during this exciting time as my client bring their products to market.



Responsibilities:

• Supporting design and development of our product including concept development, high-level design feasibility, prototype development, detailed design and DFM, design verification/validation activities.
• Application of new and existing technologies, materials and processes to deliver the optimum product design ensuring excellent standards of performance.
• Introduce/develop new equipment and production processes as required for any new manufacturing techniques.
• Working with Key Opinion Leaders (KOLs), physicians and patient representatives translating customer needs into technical solutions to improve patient care.
• Preparation of technical documentation in accordance with regulatory and design control requirements and with the company's development processes.
• Conducting sophisticated data analysis and developing detailed reports documenting results, conclusions and recommendations.
• Using Engineering problem solving tools to execute root cause investigations.
• Engaging with Vendors and suppliers on a regular basis to ensure efficient delivery of services.
• Participating in test method development and test method validation.
• Monitoring of equipment maintenance calibration and upkeep of the Engineering lab.

• Experience in medical device design principals, material selection, design concept validation and test method development a must have.
• Demonstrated understanding of various types of manufacturing, mechanisms, materials, tolerance-analysis and design-for-manufacturing principles.
• Experience of working under medical device design controls, with proven knowledge of design verification/validation and design/process FMEAs.
• Proficiency with CAD software (Solidworks) is required.
• Experience with lab equipment such as UV bonding equipment, microscopes, tensile testing machines.
• Experience of medical device regulations including GMP (Good Manufacturing Practices), QSR (Quality Systems Regulations) and ISO quality requirements is required.
• Strong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience is required.
• Excellent problem solving, decision making and root cause analysis skills are desired (DMAIC)