Senior R&D Engineer - Valve Testing

Edwards Lifesciences•Irvine, CA

1d•$106,000 - $149,000

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. 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. Edwards Lifesciences is seeking a highly skilled engineer to join our Implant 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 valve 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 partners 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 of Engineering in Mechanical Engineering, Biomedical Engineering, or related field and a minimum of 4 years experience
Master’s degree of Engineering in Mechanical Engineering, Biomedical Engineering, 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.
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.
Strong understanding of statistical techniques and engineering tools such as MS Excel, MATLAB, Minitab, SolidWorks, and Python.
Engineering experience in a regulated industry, preferably in cardiovascular implantable devices.
Experience with testing heart valves in compliance with the ISO 5840 standard is preferred.
Familiarity with product lifecycle management (PLM) and document control
Experience with authoring deliverables for regulatory submissions to regulatory authorities including the FDA

Responsibilities

Own test plans for evaluating the performance of transcatheter heart valve designs.
Deliver credible evidence enabling assessment of hemodynamic performance, durability, resistance to embolization, and interactions with delivery catheter system and patient anatomy under clinically relevant use conditions.
Apply knowledge of transcatheter valve replacement techniques to interrogate intraprocedural valve performance and predict valve performance throughout the intended lifecycle of the device.
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 valve performance under complex and novel use conditions to support indication expansion projects. Experience with CAD design and drawings as well as manufacturing techniques (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 Delivery System 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.) as well as biomaterials (pericardial tissue) 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