Edwards Lifesciences Staff Value Engineer – Critical Care Operations in Irvine, California
Have you been searching for a role that brings you to the forefront of innovation? We have an
outstanding Staff Value Engineer opportunity for you to join Edwards Lifesciences Critical Care and Surgical Monitoring Business. Be part of a patient focused culture who collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives.
The Staff Value Engineer is a key technical role that supports manufacturing sites and divisional functions to drive design changes for value improvement projects. This position is responsible for owning existing product designs and value driven engineering for Edwards Lifesciences Critical Care Operations Engineering.
The Staff Engineer will help to accomplish the redesigning of established products for greater value and lower cost. This role will provide the 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. This person will guide the establishment of test criteria and test method development to establish the device performance. This person will collaborate within a cross-functional team to define and accomplish the development and validation strategies. The ideal candidate will have experience with the early product development process and creation of design specifications.
Essential job functions:
Responsibility to support design projects for established products targeted to add value, stay current with regulatory requirements, and proactively pre-empt obsolescence.
Evaluate existing design features and establish the functional design requirements that meet customer needs.
Create 3D CAD models of design concepts to be evaluated.
Lead the generation of ideas for the Value Engineering pipeline of projects.
Development of new test methods to characterize design concepts.
Perform design characterization studies, including identification of design margins and reliability evaluation.
Writing Design Verification protocols and test reports with good documentation practices.
Provide leadership and critical thinking to cross-functional teams.
Provide subject matter expertise in matters of design control for established Critical Care products.
Develop, characterize, and implement new manufacturing processes that improve Critical Care’s capability globally.
Liaison between manufacturing sites, NPD R&D, and divisional functions.
Answering questions from regulatory agencies during submissions to international countries.
Travel up to 25%.
Perform other duties and responsibilities as assigned.
Bachelor's degree in engineering or scientific.
6 years of manufacturing engineering experience.
Experience with tolerance analysis, mechanical design, and Geometric Dimensioning and Tolerancing (GD&T) is required.
Mechanical engineer is highly preferred.
Master’s degree is preferred.
Medical device manufacturing industry experience preferred.
Experience with hemodynamic monitoring products (capital equipment and disposables) is preferred.
Understanding of traditional plastic manufacturing methods and components used in electro-mechanical medical devices.
Experience with Design Control, Design Verification & Validation (including Usability engineering), Design and Reliability principles. Process Validation (IQ/OQ/PQ) experience is a plus.
Demonstrate proficiency with 3D CAD modeling and good CAD design practice.
Experience with SolidWorks is preferred.
Strong understanding of engineering fundamentals, and an ability to deconstruct real world issues into root engineering causes.
Knowledge of statistics and the application of statistical tools, such as SPC and DOE is preferred.
Must be able to work with limited supervision, excellent team player, and think critically.
Strong presentation and verbal communication skills are required.
Must poses excellent technical writing 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 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.