The opportunity will reside in the Transcatheter Heart Valve (THV) Supplier Development Engineering team to provide manufacturing engineering support in the design and development of implantable devices and delivery systems to treat cardiovascular disease. Conduct engineering activities from initial product development phase through product launch. Develop manufacturing technologies to meet new product demands. Apply Design for Manufacturability (DFM) concepts, tools and analysis. Conduct reviews to ensure DFM considerations are incorporated into designs. Assess and develop supplier part capability. Work directly with suppliers to address specifications and quality requirements. Lead supplier validation activities, support initial builds and commercialization of new product introduction. Integrate new products into manufacturing. Manage product phase in/phase out activities around design, regulatory and clinical requirements. Support manufacturing readiness reviews and manage design transfers to manufacturing.
Essential job functions include:
Coordinates tooling / process capability studies as required.
Provides technical input for strategic sourcing projects, including evaluation of supplier capability, part qualification plan, specification review, product implementation and part transition to manufacturing.
Participate in technical discussions with suppliers to identify and implement improvements in products and processes.
Responsible for defining supplier qualification requirements for OEM, Contract manufacturer (components and devices) and custom materials, including supplier validations and Edwards receiving inspection fixture design for Test method validation.
Respond with a high sense of urgency to quality issues and escalate / communicate appropriately.
Ensure that Tier 1 suppliers are using capable Tier 2 suppliers for material and outside processing services.
Work with supplier to optimize processes.
Perform other duties and responsibilities as assigned.
Bachelor's degree in engineering or scientific with 4 years of engineering experience.
On-site work required.
20% travel required.
Master’s degree in Mechanical Engineering, Biomedical Engineering, or related discipline.
Medical device manufacturing experience in heart valves, stents, catheters, delivery systems and/or interventional access devices is preferred.
Experience in the use of statistical tools required (SPC, Six Sigma, DMAIC, etc.).
CAD experience using ProE or equivalent is preferred.
Effective communication skills.
Ability to work well both independently and as a member of a team is essential.
Strong analytical, problem solving and technical writing skills.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Internal Number: Req-4782
About Edwards Lifesciences LLC
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.