Senior Engineer, R&D

Edwards Lifesciences • Irvine, CA

1d • $108,000 - $153,000

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. Mitral valve disease impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in Transcatheter Mitral Valve Replacement (TMVR) is pioneering an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Mitral and Tricuspid Technologies (TMTT) 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. Edwards Lifesciences is seeking a highly skilled Senior Engineer to join our TMVR Delivery System R&D team. In this role, you will support Edwards’ mission to change the lives of patients with structured heart disease by developing best-in-class transcatheter heart valve therapies. You will play a pivotal role in delivery system development during all stages of the product development process (PDP) from therapy ideation through design verification (DV). You will directly influence device performance and patient outcomes by partnering with cross-functional teams to turn the data you generate into decisions. If you are passionate about solving complex technical problems while collaborating with world-class engineers to impact the lives of our patients, then this may be the role for you!

Requirements

• Bachelor's degree in Engineering (Mechanical Engineering or Biomedical Engineering highly preferred), or related field and a minimum of 4 years' experience
• Master’s degree in Engineering (Mechanical Engineering or Biomedical Engineering highly preferred), or related field and a minimum of 3 years' experience
• Or Ph.D. in Mechanical Engineering, Biomedical Engineering, or related field.

Nice To Haves

• Hands-on experience with test method development, fixture design, in-lab test execution, and data analysis.
• Engineering experience in a regulated industry, preferably in cardiovascular implantable devices.
• Experience with testing heart valves in compliance with the ISO 5840 standard
• Strong understanding of statistical techniques and engineering tools such as MS Excel, MATLAB, Minitab, SolidWorks, and Python.
• Experience with authoring deliverables for regulatory submissions to regulatory authorities including the FDA.
• Familiarity with product lifecycle management (PLM) and document control.
• Strong problem-solving skills and ability to lead root cause investigations.
• Excellent verbal communication and collaboration skills in a cross-functional environment, including proficiency with MS PowerPoint.
• Strong documentation and technical writing skills including proficiency with Microsoft Word.
• Familiarity with regulatory standards (ISO, FDA) and design control processes.
• Ability to work well independently and as a team member.

Responsibilities

• Own test plans for evaluating the performance of delivery system designs.
• Deliver credible evidence enabling assessment of catheter performance, including interactions with the valve and patient anatomy under clinically relevant use conditions.
• Support clinical cases as part of the device preparation team and bring clinical experience back to the development team.
• Apply knowledge of transcatheter valve replacement techniques to interrogate intraprocedural system performance and predict deployments and drive better patient outcomes.
• Collaborate with experts to develop an understanding of anatomy-device and device-device interactions. Use this data to develop test fixtures and methods to challenge catheter performance under complex and novel use conditions to support next generation projects.
• Experience with CAD design and drawings as well as manufacturing techniques (catheter shaft design, molding, machining, 3D printing) is preferred.
• Author documentation to support product development and regulatory submissions within Edwards’ design control framework. You will write protocols, execute tests, direct the activities of technicians, analyze data, and author reports.
• Collaborate effectively with cross-functional partners including Valve R&D, Manufacturing, Quality Engineering, Regulatory Affairs, and Clinical Development to ensure alignment on performance assessment strategies, results, and interpretation.
• Lead root cause investigations (RCI) to resolve high priority issues and provide insights requiring deep knowledge of valve design and performance. Apply root cause analysis tools such as fishbone, FMEA, and DOE to synthesize data from multiple modalities to provide technical insights and recommendations for design or procedural changes. Experience with traditional engineering materials (plastics, metals, etc.) is preferred.
• Use first principles to develop simplified models of device behavior to facilitate interpretation of test results and predict how design/procedural levers influence device performance outcomes.
• Employ statistical techniques to design test strategies to with the appropriate level of confidence based on an assessment of risk. Use statistical tools such as ANOVA, multivariate regression, and measurement system analysis (MSA) to interpret empirical results with an understanding of the associated uncertainty and implications for hypothesis testing.
• Communicate your ideas and findings effectively including authoring reports and technical summaries for regulatory submissions, preparing and delivering presentations to cross-functional stakeholders, and collaborating and coordinating with colleagues at all levels including other engineers, technicians, and leadership.
• Document methodologies and findings in compliance with internal standards and regulatory requirements.
• Train, coach, and guide other employees

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