CroíValve are looking for a Senior Clinical Development 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 officeKey Responsibilities and DutiesProcess patient echocardiography exams, CT scans using DICOM and CT analysis software (Mimics) to determine patient compatibility with DUO system and patient inclusion in clinical studies.Provide technical support for clinical trials including physician training, proctoring procedures and follow up visits.Complete analysis of patient follow up data and summarise this into reports on product performance, safety and efficacy.Make recommendations on design iterations and updates for existing and future designs using knowledge developed from patient screening, implant procedures and follow up imaging.Lead or contribute to investigations into procedural findings.Educate clinical investigators on clinical trial protocols, clinical processes, and investigational products and features.Investigate and define clinical requirements for new product/feature development and facilitate translation into new projects through clinical review and evaluation.Work with medical personnel to define the benchmarks for evaluating the clinical performance of products/features.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.Working with a cross functional team, develop and maintain physician training and educational materials.Ability to travel to for a minimum of 50% of normal working time is required.Technical: Strong clinical capability with detailed understanding of device function, patient anatomy and imaging used to implant transcatheter heart valves. Applies extensive clinical expertise for areas under their responsibility. Provides solutions to difficult clinical issues associated with specific projects.Problem Solving: Supports a culture of data-driven problem solving that ensures development of high quality devices. Promotes best practice in relation to capture, analysis and communication of data to feed into clinical decision-making across the company.Innovation/ IP: Contributes new ideas to company’s IP portfolio through disclosures.Project Management: Effective project management skills, including planning, scenario and contingency mapping. Management of activities, including delegation of discrete work package to more junior engineers. Ensures timelines are met. Effective in identifying and communicating project risks and requirements to mitigate these risks. Contributes through self and others to ensure completion of projects.Initiative: Takes initiative to drive continuous improvement and reach business objectives. Leads discussions to drive team decisions as required.People Skills: Strong ability to build relationships, both internally and externally, and resolve people issues that arise. Positively influences team and cross-functional interactions. Mentors junior team members and sets a positive example for the team, encouraging growth of more junior engineering staff.Communication: Demonstrated ability to communicate effectively with internal and external stakeholders, particularly within the clinical community. Strong presentation of medical information to guide the decision-making process.Qualifications and ExpeirenceB.S. or masters degree in science, engineering or related disciplinesMinimum of four years of related experience in medical device clinical trials.Class III medical product development experience preferred. Prior experience in cardiovascular/nitinol/delivery system medical products highly preferredProject management skills - capable of operating and liaison at all levels including managerial, project and technical.Ability to manage self and others to achieve challenging targets.Demonstrated analytical problem-solving abilities to understand clinical findings.Detailed knowledge of Design Controls and FDA, GMP, QSR and ISO 13485 requirements.Experience interfacing with clinicians and responding to feedback to ensure clear alignment on device/patient interactionsFluent in medical procedure terminology and sound knowledge of cardiac anatomyKnowledge of imaging modalities including CT, echo and fluoroscopyExperience in case support preferredExcellent communication, organizational and time management skillsFlexibility to travel to clinical sites to support project activities.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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