Edwards Lifesciences Senior Engineer, TMTT Clinical Development in Irvine, California
Senior Engineer, Clinical Development Engineering TMTT
A very exciting opportunity to work with the PASCAL Clinical Development Engineering team on supporting current and next generation activities. This position allows for exposure to technical early stage prototyping in collaboration with R&D, testing and procedural development for new designs, development of internal and external clinical training materials, and clinical case exposure to commercial cases, clinical trials and initial cases with new technologies.
Applies knowledge of technical principles and Edwards systems/procedures to optimize procedure and testing processes.
Responsible for day-to-day tasks of supporting early stage, FIH, clinical, and commercial PASCAL programs.
Assist in development and execution of internal and physician training plans for global clinical trials and commercial launches.
Develop complex experiments and tests (including writing and executing protocols) to qualify and validate testing models and processes; analyze results, make recommendations, and develop reports.
Assess, analyze, and resolve complex Clinical and Technical issues.
Develop training and documentation materials (e.g., work instructions) for procedure based on testing.
Bachelor's Degree in Engineering or Scientific field.
4 years of R&D & Clinical experience.
Excellent computer skills in usage of MS Office Suite.
CAD experience and experience in mechanical design.
Basic understanding of statistical techniques preferred.
Previous experience working with lab equipment preferred (if applicable)
Experience with clinical imaging modalities (echocardiography, fluoroscopy, CT, etc.) and case support preferred
Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills.
Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering.
Strong problem-solving, organizational, analytical, and critical thinking skills.
Substantial understanding of processes and equipment used in assigned work.
Good leadership skills and ability to influence change.
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 inter-departmental teams and key contact representing the organization on contracts or projects.
Basic documentation, communication (e.g., written and verbal) and interpersonal relationship skills.
Ability to travel 15-20%
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.