Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety.
You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle.
Your work will involve you optimizing product development to impact patients around the world with pioneering technology.
How you will make an impact:
As R&D Design Assurance Engineer in the field of innovative cardiovascular products, you will:
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Perform quality activities per ISO 13485/FDA 21 CFR part 820 related to design control (e.g., design requirements, risk management, design verification and validation, design reviews)
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Generate and/or review documents such as: design documents, drawings, work instructions, root cause analysis
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Support R&D activities of early-stage development (e.g., root cause analysis, testing, documentation)/
What you’ll need (Required):
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B.Sc. in Mechanical or Biomedical Engineering, or equivalent
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3-5 years of experience in medical device field or equivalent
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2 years of experience in R&D environment
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Quality Management System experience in medical devices
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High technical skills, hands-on
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Great interpersonal relationship
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Proficient in English and technical writing
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Organized and meticulous, detailed-oriented
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Strong problem-solving and critical thinking skills
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Independence and prioritizing abilities.
What else we look for (Preferred):
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Cardiovascular medical device experience
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Knowledge in statistical techniques
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Project management experience in medical devices
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Former employee of a large international company / Interactions with business units in US
Top Skills
What We Do
Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more.
Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today.
Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives.
Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life.
For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms
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