Edwards Lifesciences Sr Engineer, Systems & Test Automation, Critical Care R&D in Irvine, California
This is an exciting opportunity to join Edwards Lifesciences' Systems & Test Automation team in Critical Care R&D. The Sr Engineer will be responsible for developing unique test automation solutions for R&D new product development (NPD).
Job Functions / Responsibilities:
Drive the development and deployment of custom test systems / automation, and test methods concurrently with new product development as part of the R&D new product development teams.
Design, develop, and qualify test fixturing / tooling, test equipment and/or test methods to be used in new product device qualification testing.
Develop automation solutions to optimize existing tests to drive test efficiency.
Independently lead development projects with internal or external suppliers.
Create / optimize test methods associated with custom test solutions.
Develop verification strategy, testing methods and V&V plans based on product requirements and system design including writing tests that challenge the system and its requirements and advocate for test approaches that have highest impact.
Support equipment and test validation activities including creating test system requirements, equipment qualification (SWV, IQ) and test method validation protocols/reports, fixture drawings and change control.
Generate and execute feasibility studies, product verification protocols / reports and technical reports.
Employ use of statistical analysis techniques and statistical experimental design.
Perform other duties and responsibilities as assigned.
Bachelor's Degree in an engineering discipline. Mechanical, Biomedical, or Electrical Engineering preferred
4+ years of related engineering experience in medical device or similar regulated industry
Demonstrated capability in software and hardware system testing, test design and data analysis. Experience with mechanical systems is a plus.
LabVIEW, TestStand, VeriStand, C, C++, C#, .NET, and/or Python programming experience desired. Experience in MATLAB or other simulation tools a plus.
Data acquisition or programming experience preferred.
Prior experience in automation and/or robotics desirable.
Experience in equipment validation and test method validation desirable.
Able to coordinate and manage development of test fixturing. Fixture design experience desirable. CAD (Solidworks) experience a plus.
Solid problem-solving, organizational, analytical and critical thinking skills
Troubleshooting mindset, able to systematically and effectively break down a system or process into subparts to identify failure mechanisms
Ability to work well both independently and as a member of a cross-functional team in a dynamic environment is essential.
Excellent teamwork and interpersonal skills including negotiating and relationship management
Able to effectively articulate results and conclusions, verbally and in writing, to technical and non-technical personnel. Must have strong technical writing skills.
Solid understanding and knowledge of engineering principles, theories, and concepts
Capability to quickly learn and interpret complex test systems is required.
Must be a highly motivated self-starter who is driven to achieve quality and value-add results with appropriate direction. Candidate must seek direction when appropriate.
Ability to build productive internal/external working relationships.
Working knowledge and understanding of statistical techniques required
Proficiency in Microsoft Office Suite and Minitab required
Clear understanding of good documentation practices and medical device quality system regulations and requirements
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.