Edwards Lifesciences Staff Engineer, Design Assurance (Advanced Technology) in Irvine, California
This is a unique opportunity to join an innovative team within Edwards' Advanced Technology group and partner in the development and delivery of novel cardiovascular devices/therapies to benefit patients around the world.
This position will involve activities within various stages of new product development (NPD), requiring collaboration with a cross-functional design team, with the goal of providing quality leadership and vision throughout the initial product development cycle up to commercialization, while ensuring compliance to applicable internal and external requirements. In this position, the engineer will work closely with R&D to define strategy, as well as refine and finalize the design per the NPD process. In addition, the engineer will work with the Operations team to help facilitate successful transfer/launching of robust products. This position provides an opportunity to work in a fast paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success.
Key Job Functions:
Collaborate with the R&D and Operations teams in the areas of Design Engineering, Risk Management, Design Controls, Design Verification, Statistical Techniques, Test Method Development, Process Development, Quality Assurance, and Regulatory Compliance.
Lead Risk Management process for project in compliance to appropriate external standards and corporate policies, to ensure critical to quality features are identified and addressed appropriately.
Provide integral technical input for the development of project plans, project timelines and strategy to support premarket approval of products.
Partner with R&D engineers to support design verification/validation strategy and testing, including test method development/validation activities.
Influence with other leaders in project and across the organization.
Mentor engineers in understanding of quality systems and strategies within new product development.
Support root cause investigations/product evaluations for product failures encountered during clinical use.
Support resolution of manufacturing and compliance issues (i.e. CAPA, non-conformances, audit observations, etc.) utilizing problem solving tools.
Support Quality Engineering activities to improve customer satisfaction and successful achievement of company quality objectives.
Responsible for ensuring compliance with all National/Federal, local, and company regulations, policies and procedures.
Education and Minimum Requirements:
Bachelor’s degree in engineering and a minimum of 6 years of relevant experience within the medical device industry, or a combination of medical device and another highly regulated industry
Master's degree in engineering and a minimum of 5 years of relevant experience within the medical device industry, or a combination of medical device and another highly regulated industry.
- First-in-human (FIH) engineering experience for class III implantable devices
In-depth knowledge of Design Control, Risk Management, and related standards, as applicable for medical devices.
Strong technical and analytical engineering skills. Able to understand drawings and device design at a practical level.
Excellent verbal and written communication skills. Able to communicate clearly and concisely yet thoroughly.
Ability to handle multiple tasks simultaneously.
Must be accurate in handling detailed information/data.
Experience in Design for Manufacturing (DFM) preferred.
Experience with electronic devices, data transmission/acquisition a plus.
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.