Senior R&D Clinical Engineer



Our client a high potential start up are currently seeking a Senior R&D Clinical Engineer to join their team. Reporting to Head of R&D the Senior R&D Clinical Engineer will support the product development of a cutting edge device through design development, verification, clinical trials, validation and regulatory approval. This role can be either office based or fully remote.



Role/Responsibilities

• Responsible for screening of patients as part of the device clinical studies
• Using knowledge of the device, right heart anatomy, physiology and pathology, process patient echocardiography exams and CT scans using DICOM and CT analysis software (Mimics) to make recommendations for patient inclusion in clinical studies
• 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 and follow up, as well as anatomical analysis of patient CTs.
• Working with a cross functional team, develop and maintain physician training and educational materials.
• Provide hands on case support in the form of delivery of training materials to physicians, preparation of the device in the cath lab and physician proctoring during cases.
• Provide R&D expertise to lead investigations into procedural complaints as they may arise.
• Using the knowledge and insight gained from the clinical environment, develop test methods for product evaluation and validation. Develop and execute test method validations.
• Provide technical and project leadership for R&D activities as required.
• Leverage and liaise with external resources to achieve project goals.
• Lead user related risk management activities and act as subject matter expert for inputs to other risk management efforts as it pertains to the device design and clinical use.
• Ensure quality in the product’s design for durability, usability, reliability, functionality, marketability, and manufacturability

Skills/Experience

• B.S. or master degree in mechanical engineering, biomedical engineering, or related discipline.
• Five years of related experience in medical device mechanical design/product development in cardiovascular devices, with experience on structural heart devices strongly preferred.
• Strong design and technical ability based on a broad and deep knowledge of fundamental engineering principles. Prior experience in cardiovascular/nitinol/delivery system medical products highly preferred
• Strong capability of assessing in vitro and in vivo properties of device/device components including knowledge of the implant/tissue interface and challenges.
• Hands on experience in anatomical analysis and anatomical data processing to input to device design and case planning using anatomical analysis software (e.g. Mimics, Radiant or similar).
• Hands on experience using CAD software (Solidworks preferred).
• Detailed knowledge of Design Controls and FDA, GMP, QSR and ISO 13485 requirements.
• Experience interfacing with clinicians as part of case support activities.
• Excellent organizational and time management skills.

For further information please contact James Cassidy [email protected] or call in confidence 086 0204322