Irvine, CA, 92604, USA
1 day ago
Principal Engineer, Cardiac Biosimulations, Clinical Development
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. Patients are at the heart of everything we do. As part of our Medical Affairs team, you’ll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. **How you’ll make an impact:** + Provides expertise in the optimization of product development & clinical practical application. + Lead in the improvement, design and optimization of more complex experiments, tests, analyze results, provide complex recommendations, and develop reports, based on engineering principles that translate to clinical impact. + Oversee R&D-style support tasks for clinical & commercial evidence generation; give instruction to technicians/engineers on conducting tests; train technicians/engineers and provide feedback; and coordinate technician/engineer work. + Proactively identify new solutions to clinical questions, achieve practical approaches to substantiate marketing claims. + Impact patient pool differentiation problems of significant complexity with the broad TMTT portfolio of repair and replace by collaboration with KOLs and internal research projects requiring designing parts, components and subsystems as needed. + Generate test methods, podium data, white papers, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specifications. + Create/update complex design control documents including requirement specs, and risk documents with robust knowledge on design control requirements. + Develop project plans to assess technology and drive project results. + Train, coach, and guide lower level engineers on more complex procedures, and test methods. **What you'll need (Required):** + Bachelor's Degree in Engineering or Scientific field, minimum of 6 years of experience, including either industry or industry/education Required or + Master's Degree or equivalent in Engineering or Scientific field, minimum of 5 years of experience, including either industry or industry/education Required or + Ph.D. or equivalent in Engineering or Scientific field **_preferred_** , minimum of 2 years of experience, including either industry or industry/education Required + 25% travel international and domestic **What else we look for (Preferred):** + Med Tech and Aerospace Industry experience. + Proficiency in matlab, python or similar. + Strong Data visualization skills + Proficiency in clinical understanding and advanced cardiovascular structural disease knowledge. + Excellent documentation and communication skills. + Excellent interpersonal relationship skills including negotiating and relationship management skills. + Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering + Advanced problem-solving, organizational, analytical and critical thinking skills + Extensive understanding of processes and equipment used in assigned work + Ability to influence others + Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing + Strict attention to detail + Ability to interact professionally with all organizational levels + Ability to manage competing priorities in a fast paced environment + Must be able to work in a team environment, including frequent inter-organizational and outside customer contacts + Represents organization in providing solutions to difficult technical issues associated with specific projects + Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control 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. For California (CA), the base pay range for this position is $118,000 to $167,000 (highly experienced). 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. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. **COVID Vaccination Requirement** 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.
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