Edwards Lifesciences Engineer II, Clinical Development - Transcatheter Mitral and Tricuspid Therapies in Irvine, California
This is a unique opportunity to play a critical role in the growth of new cutting-edge heart valve therapies for Transcatheter Mitral and Tricuspid Therapies (TMTT). As an Engineer within TMTT Clinical Development, you will have direct impact on procedural development of our technologies as we bring early-stage technologies through Clinical Trials and toward commercial markets. This role applies knowledge of technical principles and Edwards systems/procedures to optimize clinical development activities in support of TMTT devices.
Provide clinical design inputs and collaborate with product development teams to provide feedback on device iterations and new device development
Support procedural development and develop procedural techniques for FIH and early clinical studies
Provide on-site, real-time guidance during clinical implants and document procedural case observations for learning and training updates
Design, prepare and conduct First In Human product evaluations, including some case support for proper product use and feedback collection
Develop, review, and update clinical design control documents, including technical summaries and design validation protocols/reports
Develop patient selection criteria and manage patient screening process for FIH and early clinical studies
Collect and analyze data from early human use studies and perform literature/competitive reviews
Other duties assigned by Leadership
Bachelor's Degree in Engineering and 2 years industry experience
Master's Degree in Engineering with internship, senior projects, or thesis in industry or industry/education
Medical device experience in R&D or Clinical role, with Class III transcatheter device experience
Experience in the Cath Lab or Operating Room environment is preferred
Experience with medical device early feasibility studies and clinical trials
Good computer skills in usage of MS Office Suite; CAD experience preferred
Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
Basic understanding of statistical techniques
Previous experience working with lab/industrial equipment required (if applicable)
Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
Solid problem-solving, organizational, analytical and critical thinking skills
Solid understanding of processes and equipment used in assigned work
Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
Knowledge of applicable FDA regulations for medical device industry
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 EHS rules and requirements 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
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.