Edwards Lifesciences Sr. Quality Engineer, New Product Development - Design Assurance (TMTT) in Irvine, California
This is a unique opportunity to join an innovative development team within the Edwards Transcatheter Mitral & Tricuspid Therapies business unit. TMTT is dedicated to lead and transform treatment for patients with mitral and tricuspid valve disease.
The position of Senior Engineer, Design Assurance will collaborate with the cross-functional design team in development of the next generation mitral/tricuspid repair system, while ensuring compliance to applicable internal and external requirements during the product development cycle and commercialization of new products. In this position, the engineer will work closely with R&D to refine and finalize the design per the new product development process, as well as with the Operations team to help facilitate successful transfer/launch 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. This position will allow involvement with various stages of new product development (NPD) through device commercialization.
Collaborate with the R&D organization to help facilitate the successful execution of the new product development process and launching of safe and effective products in compliance with external regulations and corporate procedures.
Provides expertise in the areas of Quality Assurance, Design Controls, Risk Management, Statistical Techniques, and Regulatory Compliance
Leverage strong technical and collaboration skills for quality engineering related support of product development, new product introduction, process development (both internal and external), and operations.
Facilitate Risk Management process in compliance with appropriate external standards and corporate procedures to ensure critical to quality features are identified and addressed appropriately.
Partner with R&D to develop and perform design verification/validation testing, including test method development/validation activities.
Support root cause investigations for manufacturing issues and product failures by utilizing problem solving tools.
Maintains an up to date knowledge in the areas of Quality Assurance, Design Controls, Risk Management, Statistical Techniques, and Regulatory Compliance. Maintains an up to date knowledge of the company products, policies, and procedures.
Education and Minimum Requirements:
Bachelor's Degree in Engineering and a minimum of four (4) years of experience within the medical device industry, or a combination of medical device and other related regulated environment experience
Master's Degree in Engineering and a minimum of three (3) years of experience within the medical device industry, or a combination of medical device and other related regulated environment experience
NPD and design assurance experience for a class III (implantable) medical device manufacturer
Additional Talents and General Expectations:
Hands-on experience with implant/catheter design, materials, inspection/testing and manufacturing processes.
Strong technical engineering skills. Able to understand drawings and device design at a practical level.
Working knowledge and understanding of statistical skills.
Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills.
Ability to handle multiple tasks simultaneously and ability to manage project timelines.
Must be accurate in handling detailed information/data.
Ability to interact professionally and work in a team environment.
Knowledge of and adherence to Quality systems.
Good leadership skills and ability to influence change.
Strong problem-solving, analytical and critical thinking skills.
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.