Overview Design, development and taking to market of medical devices for one or more Cook Medical Strategic Business Units.
Reporting to: Team Lead Research and Development / Manager, Research and Development
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Responsibilities 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. Communications: 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. Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf. Qualifications Bachelor's degree in Engineering or a related field is required. Minimum of 3 years' relevant experience is required Demonstrated project planning skills. Execution of project in a timely effective manner. Knowledge of anatomy and physiology is preferred. 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), EU Medical Device Regulation 2017/745. 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. About Cook Limerick Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook's products for global markets.
Research and Development in Limerick Our mission with R&D is to invent, manufacture, and deliver a unique portfolio of medical devices to the healthcare systems of the world. Our R&D team in Limerick is split into two divisions, Vascular and Medsurg. The R&D engineering teams are responsible for bringing a product from idea or concept all the way to market launch. The MedSurg R&D team in Limerick has two programs, Endoscopy/EndoSurgery and Otolaryngology Head and Neck Surgery (OHNS) that it is responsible for designing and developing new and innovative products for. The R&D engineers and scientists have the opportunity to explore and create novel ideas within feasibility, bring a medical device through verification and validation phase and be a part of bringing a new product to the market. The MedSurg R&D team works in collaboration with Cook's sister site in Winston Salem, North Carolina.?
Our employee benefits include: Hybrid Work Model Company sponsored Defined Contribution pension scheme Medical Health Insurance cover for you and your immediate family Life Assurance and Income Protection cover Educational Assistance Performance related Bonus Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks Fully equipped gym on site 39-hour week with flexible start & finish times Paid time off to participate in volunteer activities Free parking Subsidised restaurant Sports & Social club #LI-Hybrid
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