Edwards Lifesciences Sr. Engineer, Clinical Development in Irvine, California
We have an exciting opportunity to work with the PASCAL Clinical Development Engineering team on supporting next-generation and commercial launch activities. This position allows for exposure to technical early-stage prototyping in collaboration with R&D, testing procedural development of new designs, and clinical case exposure to initial and commercial cases with new technologies.
Applies knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes.
• Identify and ensure implementation of opportunities to optimize/improve simulation models for next-generation device testing employing technical design skills to re-design/design of equipment, tools, fixtures, etc. are up to standards
• Develop complex experiments and tests (including writing and executing protocols) to qualify and validate testing models processes; analyze results, make recommendations, and develop reports
• Analyze and resolve complex Clinical and Technical issues
•Perform imaging case reviews and perform complaint evaluations
• Develop training and documentation materials (e.g., work instructions) for the procedure based off of testing
• Lead and establish project plans to ensure deliverables are completed to customer expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
• Other incidental duties assigned by Leadership
Education and Experience:
Bachelors' Degree in Engineering or Scientific field required with 4- years' experience including either industry or industry/education required
Masters' Degree or equivalent in Engineering or Scientific field with, 3 -5 years' experience including either industry or industry/education Required or Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education Required
• Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
• Basic understanding of statistical techniques
• Strong Test Method development experience
• Previous experience working with lab/industrial equipment required (if applicable)
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Strong problem-solving, organizational, analytical and critical thinking skills
• Substantial knowledge of processes and equipment used in assigned work
• Good leadership skills and ability to influence change
• Knowledge of applicable FDA regulations for the 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
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 13,000 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.