Job Title: Research & Development Engineer
Reporting to: Senior Research & Development Engineer/Research & Development Manager
Perform Duties of Research & Development Engineer:
• Design development, prototyping, test method design, design evaluation , design reviews, design specifications, design verification and validation, design protocols and reports, transfer to production activities in a timely effective manner.
• Product testing and evaluation, completion of test reports to support design selection.
• Preparation and presentation of design reviews.
• Product and project risk analysis and risk management.
• Work with Process Development Engineering to introduce/develop new equipment and production processes as required for any new manufacturing techniques.
• Source new materials components and equipment.
• Development of component specifications, inspection methods, bills of materials and manufacturing processes.
• Introduction of new equipment, materials and technologies.
• Work closely with Key Opinion Leaders (KOL’s), physicians and product managers to develop innovative medical devices to improve patient care.
• Project lead for assigned research & development projects including technical and project management responsibly.
• Manage and drive project tasks to ensure timely completion of project milestones.
• Work closely with cross functional groups to achieve project and company goals.
• Product performance evaluations.
• Contribute to innovation and creativity within team through filing of disclosures and patents.
• Hold regular project meetings and document minutes and actions.
• Ensure project milestones are achieved to meet business metrics.
• Compliance with Quality, Regulatory and company policies and systems.
• Regular communication to cross-functional teams, senior management and business unit leaders.
• Project status communications and reporting.
• Remain on the forefront of emerging industry practices.
• Educating oneself in the medical area for which the new devices are being developed in order to have an appreciation for what needs to be achieved with these products.
• Support other cross functional groups to deliver company goals.
• Third level degree in Mechanical, Biomedical, Design, Chemical Engineering or similar discipline.
• 2 Years design experience medical device roles.
• Project planning skills.
• Knowledge of anatomy and physiology.
• Good mechanical design and understanding of engineering fundamentals with extensive medical device materials knowledge.
• Manufacturing design and process understanding.
• Good working knowledge of Solidworks and/or Pro Engineer CAD.
• Strong technical writer.
• Knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820).
• Team Player with ability to develop strong working relationships.
• Strong communication and inter-personal skills.
• Good problem solving skills.
• Highly motivated individual, self-starter with a passion for excellence.
• Must be able to work in a fast paced environment.
• Willingness and availability to travel on company business.
Clodagh Nerney | Tel: +353 (0) 1 507 9254