Edwards Lifesciences Senior R&D Engineer, Supplier Value Improvement in Irvine, California
The SeniorR&D Engineer is a key technical role that supports manufacturing sites and divisional functions. This position is responsible for owning value driven engineering project execution for Edwards Global Supply Chain Operations Engineering and will provide engineering knowledge and critical thinking to the validation of changes that affect the design, cost and quality of existing Edwards Lifesciences products.
The Senior R&D Engineer will collaborate with key Edwards Lifesciences suppliers in the redesigning of established products and components to deliver greater value and lower cost with improved quality.
This person will:
Provide knowledge of customer needs and design features to assess and establish the engineering requirements that are essential for the performance and quality of the device. Guide the establishment of test criteria and test method development to establish the device performance. Collaborate within a cross-functional team to define and accomplish the development and validation strategies and lead the validation efforts.
Key responsibilities include:
Responsibility to support design projects for established products and components targeted to add value, stay current with regulatory requirements, and proactively improve process capability and quality.
Collaborate closely with key suppliers on high value purchased products and components with the ability to ID cost drivers and process or other issues impacting quality and cost.
Evaluate existing design features and define the functional design requirements that meet customer needs.
Provide leadership and critical thinking to cross-functional teams and in collaboration with suppliers.
Provide subject matter expertise in matters of design control for established products.Develop, characterize, and implement new manufacturing processes that improve manufacturing capability and cost globally.
Support facility, equipment, product, process validations, troubleshooting and ongoing improvements.
Liaison between manufacturing sites, NPD R&D, Quality, Regulatory Affairs, and corporate/divisional functions.
Encourage the adoption of best practices throughout Global Supply Chain, in areas such as six sigma and lean.
Perform other duties and responsibilities as assigned.
A Bachelor's Degree in engineering is required plus 4 years of manufacturing value engineering experience or Master’s Degree plus 3 years of related experience.
The ideal candidate will have experience with the new product development process and creation of design specifications.
Medical Device experience in product feasibility and validation is required.
Experience collaborating with suppliers on value creation projects is preferred.
Must have good collaboration and facilitation skills in leading technical workshops and discussions targeted to identify cost drivers and best value creation levers.
Must have a good understanding of traditional plastic manufacturing methods and familiarity with automation.
Must be able to work with limited supervision, think critically, and communicate effectively.
A strong understanding of engineering fundamentals, and an ability to deconstruct real world issues into root engineering causes are required.
Knowledge of statistics and the application of statistical tools, such as SPC and DOE is preferred.
Strong interpersonal and verbal and written communication skills are required.
Must have a willingness to travel up to 20-25% of the time.
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.