Imagine how your ideas and expertise can change a patient’s life. Our Design Assurance 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 R&D 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 impact:
Lead Risk Management activities (including authoring risk management documents).
Collaborate with R&D teams to identify and generate product requirements and ensure regulatory compliance.
Responsible for adhering to company SDLC procedures and approving development documentation.
Collaborate with stakeholders on the Code Review process for software product.
Review and approve SW V&V and system DV and Dval plans and reports.
Responsible for TMV for both development and process test methods.
Ensure early focus on manufacturability in NPI programs.
Perform other duties and responsibilities as assigned.
What you'll need: (Required)
Bachelor’s degree in Computer Science/ Engineering, Biomedical Engineering, or combination of “STEM” Majors (Science, Technology, Engineering and Math) with Software courses
6+ years of relevant experience in medical device development.
Experience with leading risk management and requirements & tests traceability.
Experience in medical device regulatory standards for SW life cycle.
What else we look for: (Preferred)
Experience in HW testing and qualification (HALT HASS, IEC 60601 standards).
Experience in usability (IEC 62366) and GUI development.
Experience with a host of communication protocols: I2C, RS422, USB, HDMI, TCPIP.
Experience in system engineering
Other Skills:
Strong documentation
Must be able to work in a team environment, including inter-departmental teams.
Strong problem-solving, organizational, analytical and critical thinking skills.
Substantial understanding of processes and equipment used in assigned work.
Strict attention to details.
Ability to manage competing priorities in a fast-paced environment
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
