OverviewThe primary responsibility of this position is to support / lead on the design, development and taking to market of medical devices for Cook Medical.
Reporting to: Team Lead, Research and Development / Manager, Research and Development
ResponsibilitiesPerform Duties of Research & Development Engineer 2: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 risk analysis and risk management.Contribute towards process development during introduction / development of 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.As required work closely with Key Opinion Leaders, physicians, product managers and team to develop innovative medical devices to improve patient care.Work closely with Project Lead and take responsibility for assigned research and development project tasks:Manage and drive assigned 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.Communications:Regular communication to cross-functional teams and senior management.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.QualificationsBachelor's degree is required, preferably in engineering or a related field.Minimum of 3 years' relevant experience is desired.Project planning/execution skills.Execution of project in a timely effective manner.Knowledge of anatomy and physiology.Good mechanical design and understanding of engineering fundamentals with medical device materials knowledge.Statistical understanding and experience.Manufacturing design and process understanding.Good working knowledge of Solidworks and/or Pro Engineer CAD.Strong technical writer.Knowledge of relevant ISO, EU, FDA medical device standards regulations is required.Willingness and availability to travel on company business.
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