Irvine, CA, 92604, USA
1 day ago
Principal Engineer, R&D
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. We are looking for an exceptional **Principal R&D Engineer** with a strong track record in leading medical device development, guiding technical direction through design characterization and testing, and thriving in collaborative environments to create and implement practical technical solutions. **How you’ll make an impact:** + Lead the design of distal ends of TAVR delivery systems and optimize the system interaction with valves, sheaths and accessories. + Proactively identify issues, achieve resolution, and resolve problems of significant complexity on designing parts, components, subsystems or system interaction. + Set up and execute complex experiments and tests, analyze results, provide complex recommendations, and develop reports, based on engineering principles that translate to innovative products + Execute and oversee R&D support tasks; give instruction to technicians/engineers on conducting tests; train technicians/engineers and provide feedback; and coordinate technician/engineer work. + Generate work instructions, test methods, 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 employees on more complex procedures + Other incidental duties as assigned by leadership **What you'll need (Required):** + Bachelor’s degree in Engineering or a Scientific field with 6+ years of experience in a highly regulated industry + Master's degree in Engineering or a Scientific field with 5+ years of experience in a highly regulated industry **What else we look for (Preferred):** + Experience with setup of study design and execution for complex tests + Six Sigma Black Belt + Medical device industry experience + Proficiency in the usage of relevant computer software + 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 + Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing + 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 + Ability to represent 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, 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.
Por favor confirme su dirección de correo electrónico: Send Email