Engineer II, R&D

Edwards Lifesciences • Irvine, CA

3d • $85,000 - $120,000

About The Position

Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our R&D Engineering team, you will work closely with our Quality and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around the world. 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. How you will make an impact : This is a rare opportunity to join a fast-paced, passionate Delivery System R&D team, within Edwards Lifesciences’ Transcatheter Mitral and Tricuspid Therapies group, working on transcatheter replacement therapies to address Tricuspid disease. This team is deeply dedicated to transforming treatment to significantly improve patient lives around the world through valve replacement and we need your talent! This Engineer II role will support the next-generation system qualification and commercialization for a product line that offers a novel, highly efficacious therapy to a broad group of patients in need. With your help, this next-generation team will enable the continued growth of an innovative platform that supports a growing transcatheter tricuspid replacement therapy.

Requirements

• Bachelor's Degree in Engineering or Scientific field with 2+ years of experience -OR- Master's Degree or equivalent in Engineering or Scientific field with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education
• 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.

Nice To Haves

• Mechanical Engineering degree strongly preferred
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering design, design verification & validation
• Catheter Manufacturing processing experience
• Medical device design & development experience
• Experience with DV&V, OQ/PQ
• Test method validation experience
• Experience with statistical techniques
• CAD experience
• 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 the ability to manage vendors and project stakeholders
• Ability to build productive internal/external working relationships
• 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

Responsibilities

• Build and evaluate products by developing complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles
• Evaluate manufacturing and clinical inputs, form technical recommendations, and help influence the design of future device iterations
• Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers
• Generate test methods, engineering models and drawings/prototypes, etc., to characterize product and/or process specifications
• Assign R&D support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback
• Create/update sophisticated design control documents
• Other duties assigned by Leadership

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees