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Biomedical Design Engineer : Heart Valve SME Stealth Mode NewCo : Well Funded Start-Up Class III Heart Valve Impant & Delivery System 1st Generation Concept Design and Development Bay Area : Hybrid Remote : Full Time Direct Hire Overview: We are seeking a skilled and innovative Heart Valve Design Engineer to join our team. This role involves designing, developing, and refining heart valve devices to improve patient outcomes and advance medical technology. The ideal candidate will possess expertise in mechanical design, biomedical engineering, and knowledge of cardiovascular physiology, with a strong emphasis on designing devices for long-term reliability, biocompatibility, and functionality. Key Responsibilities: Design and Development: Conceptualize, design, and develop heart valve devices using CAD software and advanced modeling techniques. Create detailed design specifications, conduct prototyping, and refine designs based on testing and feedback. Simulation and Analysis: Use finite element analysis (FEA) and computational fluid dynamics (CFD) to simulate valve performance under physiological conditions. Analyze results to optimize valve design for durability, flow dynamics, and mechanical performance. Prototyping and Testing: Oversee prototyping processes, collaborating with the production and materials teams to create functional prototypes. Design and execute in-vitro and in-vivo testing protocols to evaluate device performance, safety, and compliance with regulatory standards. Collaboration and Documentation: Work closely with cross-functional teams, including quality, regulatory, and manufacturing, to ensure designs meet clinical and regulatory requirements. Prepare technical documentation, including engineering drawings, design history files, and testing reports, for internal use and regulatory submissions. Research and Innovation: Stay updated on advances in materials, technologies, and heart valve therapies. Contribute to research initiatives, proposing innovative solutions to improve the functionality and safety of heart valve devices. Qualifications: ~ Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, or related field. ~3+ years of experience in heart valve design, cardiovascular devices, or related biomedical engineering roles. ~ Proficiency with CAD software (SolidWorks, AutoCAD) and simulation tools (ANSYS, Abaqus). ~ Strong understanding of cardiovascular anatomy, physiology, and hemodynamics. ~ Knowledge of regulatory standards (e.g., ISO, FDA) for medical device design is preferred. Skills: Excellent problem-solving abilities and a strong attention to detail. Ability to work collaboratively in a multidisciplinary team environment. Strong technical writing and documentation skills. Familiarity with manufacturing processes and materials used in implantable devices.