Engineer – Distinguished Level

Deep understanding of tissue, fabric, and suture development, including material science and engineering principles.
Experience in the development of material models incorporating probabilistic techniques.
Strong understanding of bioprosthetic valve design and development including testing and modelling methods.
Proficiency in using computational modeling tools like FEA (Finite Element Analysis), CFD (Computational Fluid Dynamics), and FSI (Fluid-Structure Interaction) for design and analysis.
Ability to develop and implement strategic plans that align technical capabilities with business objectives.
Strong project management skills, including resource allocation, timeline management, and the ability to handle complex projects.
Excellent collaboration skills to work effectively with cross-functional teams and communicate technical information clearly to stakeholders.
Exposure to the development of novel model validation experiments and analogous finite element modeling, as well as FEA model validation.
The candidate shall be familiar with the application of the principles of ASME VVUQ10, 20 & 40 to drive model credibility. Has prepared detailed testing, modeling and simulation engineering reports to support product design characterization and verification, for example in direct support of new product regulatory submissions.

Provide expert guidance to enhance technical understanding and capabilities in the development and design of soft goods, including tissue, fabric, and sutures.
Develop and implement strategic plans that align technical advancements with business objectives, driving growth and maintaining a competitive edge in the market.
Work collaboratively with cross-functional teams to execute comprehensive testing and modelling strategies aimed at optimizing design and assessing the reliability of Structural Heart and Aortic devices.
Cultivate a culture of innovation and continuous improvement by encouraging the adoption of new technologies and methodologies.
Provide mentorship to engineering teams, enhancing their skills in both testing and modelling in soft goods.
Lead complex projects by effectively managing resources and timelines to ensure the successful delivery of technical objectives.
Utilize FEA, CFD, or FSI software tools to develop predictive models that support the design and development of bioprosthetic heart valves.
Oversee the development and execution of comprehensive testing protocols and validation processes to ensure product safety, efficacy, and compliance with industry standards.

Significant experience using Abaqus, LS-DYNA or similar FEA software.
Extensive experience meshing complex 3D structures.
Experience with CAD software.
Knowledge of engineering mechanics, mechanical design, material processing, fatigue analysis, metallurgy and strength of materials.
Knowledge and experience with application of technical principles, theories, and design concepts in implantable product design including product, process, and technology development and evaluation.
Knowledge of risk management analysis including Failure Mode and Effects Analysis (FMEA) and statistical techniques relevant for design and test for reliability.