<p>Innovation starts from the heart. At Edwards, we put patients first. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.</p> <p>Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.</p> <p>This is an exceptional opportunity for an experienced medical device Senior Engineer with technical expertise to contribute to the cutting edge Transcatheter Heart Valve programs. This Senior Engineer position involves applying knowledge of technical principles, expertise in Computational Fluid Dynamics (CFD), Fluid Structure Interaction (FSI) as part of a team to design and develop heart valve or components in support of company's strategic plan.</p> <p>How you'll make an impact:</p> <ul> <li> <p>Collaborate with Clinical Development group to develop geometries and boundary conditions from patient reconstructions that can be applied to simulations and/or bench testing.</p> </li><li> <p>Develop complex CFD and/or FSI models to implement patient-specific geometries, boundary conditions and valve geometries to study structural and hemodynamic performance of a valve.</p> </li><li> <p>Collaborate with bench testing team to create drawing, fixtures, models and collect data in order to validate CFD, FSI models.</p> </li><li> <p>Analyze data from complex CFD, FSI models to write technical reports and make recommendations to design teams on improvements to optimize valve designs.</p> </li><li> <p>Apply biomedical and mechanical engineering principles to solve mechanical engineering problems at the component through system level.</p> </li><li> <p>Maintain accurate documentation of results and generate technical reports.</p> </li><li> <p>Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products and therapies.</p> </li><li> <p>Interface with R&D, manufacturing, clinical development, clinical affairs, quality and regulatory personnel to ensure compliance with internal and external policies and procedures, QSR, and FDA regulations.</p> </li><li> <p>Work closely with clinical development and/or physician partners in both pre-clinical and clinical environment in order to build strong knowledge and understanding of cardiovascular anatomy, structure of the heart, and valve diseases</p> </li></ul> <p>What you'll need (Required):</p> <ul> <li> <p>Bachelor's degree in mechanical, biomedical, or a related engineering discipline is required; Master's degree is highly preferred</p> </li><li> <p>2+ years of experience in the medical device industry</p> </li><li> <p>4+ years of experience in simulation using CFD, FEA, FSI with commercially available software</p> </li></ul> <p>What else we look for (Preferred):</p> <ul> <li> <p>Prior patient CT reconstruction experience using commercial software such as Materialise, Simpleware etc.</p> </li><li> <p>Prior patient CT reconstruction experience to develop boundary conditions using commercial software such as Materialise, Simpleware etc.</p> </li><li> <p>Prior experience with commercial CFD software such as XFlow, Converge, StarCCM etc. for modeling both laminal and turbulent flows</p> </li><li> <p>Prior bench testing experience with hydrodynamic testers, PIV to validate predictions of CFD, FSI models</p> </li><li> <p>Prior experience with Abaqus</p> </li><li> <p>Prior experience with SolidWorks, Creo</p> </li><li> <p>Prior cardiovascular device industry experience</p> </li><li> <p>Prior experience with submissions to the FDA and/or other regulatory bodies</p> </li><li> <p>Understanding of ASME V&V 40</p> </li><li> <p>Strong documentation skills; strong technical writing ability and good verbal communication skills</p> </li><li> <p>Effective communication, listening, and diagnostic skills are required</p> </li><li> <p>The ability to work well independently and as a team member is essential</p> </li><li> <p>Ability to interact professionally with all organizational levels</p> </li><li> <p>Ability to manage competing priorities in a fast-paced environment</p> </li></ul> <p>Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.</p> <p>For California, the base pay range for this position is $106,000 to $149,000 (highly experienced).</p> <p>The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.</p> <p>Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.</p> <p>COVID Vaccination Requirement</p> <p>Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.</p>