Senior Clinical Engineer

Title: Sr Clinical EngineerLocation: Maple Grove, MNPosition: Full-time (permanent, on-site)Position Summary:The Senior Clinical Engineer role will be responsible for investigating, translating and optimizing the VDyne Transcatheter Tricuspid Valve Replacement therapy. This position will report to the director of R&D and Therapy development, working to study device performance and make recommendations for optimizing the procedure and/or product design.The position will have a broad scope, ranging from detailed modeling of patient specific outcomes to industry wide analysis of therapy trends. Collaboration with the VDyne clinical field and R&D teams is expected. Clinical data related to the procedure and outcomes will be studied and presented to the internal VDyne team.While case support is not expected, there will be opportunities for in person observation of clinical cases requiring some travel (<10%).   This position is in-person (not remote) and based at VDYNE’s Maple Grove offices so candidates should be located in the greater Minneapolis area.Key Responsibilities:·      Anatomical analysis (segmentation and measurement) of CT scans (pre & post implant).·      Patient screening workflow optimization and algorithmic modeling for patient selection.·      Physical modeling of patient anatomy (SolidWorks, 3D printing).·      Statistical analysis of anatomy, bench and clinical data.·      Evaluation of case imaging (fluoroscopy and echo).·      Root cause investigation and analysis of case outcomes (both positive and unanticipated).·      Development of protocols/reports and performing in-vitro and in-vivo testing.·      Make recommendations for therapy direction, device iteration and product requirements as an output of clinical analysis.Experience & Skill Requirements·      BS in Mechanical Engineering, Biomedical Engineering, or related field.·      5+ years of experience in clinical engineering for class III medical devices. Structural heart experience in valves is a plus.·      Must work onsite in Maple Grove, MN·      Segmentation and anatomical modeling experience (e.g. 3mensio, 3matic).·      Technical proficiency with statistical analysis software (e.g. Minitab, JMP, MATLAB)·      Technical proficiency with design software (e.g. SolidWorks, Fusion 360)·      Experience with Good Documentation Practices (GDP) and functioning within quality systems.·      Ability to understand and comply with company policies and applicable industry laws and regulations.