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Clinical r&d engineer

Dublin
CroiValve
Engineer
Posted: 19 February
Offer description

About the RoleCroíValve are looking for a Clinical R&D Engineer to support the product development of a cutting-edge structural heart device through design development, verification, clinical trials, validation and regulatory approvals. This role is based full time in our Dublin office.Key Responsibilities and DutiesProvide technical support for clinical trials including implants and follow up visits.Educate clinical investigators on clinical trial protocols, clinical processes, and investigational products and features.Perform imaging analysis to determine suitability of clinical trial candidates.Perform detailed analysis on patient procedural and follow up imaging to facilitate patient screening and procedural improvements.Investigate and define clinical requirements for new product/feature development and facilitate translation into new projects through clinical review and evaluation.Provide input to the risk management file and clinical evaluation reports in support of the product throughout its lifecycle.Support development and testing of prototypes and validation of outputs to meet design input requirements.Education and ExperienceB.S. or masters degree in mechanical engineering, biomedical engineering, or related disciplines.0-2 years experience in medical devices..Knowledge of imaging modalities including CT, echo (TTE and TEE) and fluoroscopy.Demonstrated analytical problem-solving abilities.Experience of preparing technical documentation.Experience in medical procedure terminology and sound knowledge of cardiac anatomy preferred.Experience operating in a regulated environment, ideally medical devices is preferred.Class III medical product development experience involving clinical trials preferred.Excellent communication, organizational and time management skills.Flexibility to travel to clinical sites to support project activities.Availability to travel for a minimum of 50% of normal working time is required.The above role profile is not designed to cover a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned from time to time.

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