Edwards Lifesciences Staff Engineer, Supplier Development - Transcatheter Heart Valve in Irvine, California
The opportunity will reside in the Transcatheter Heart Valve (THV) Supplier Development Engineering team to provide supplier/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. Support R&D, NPD teams in design development and component readiness for meeting their project milestones. Research and implement manufacturing technologies to meet new product demands. Perform DFM and ensure that the feedback is incorporated into designs and manufacturing processes. Assess and develop supplier process capabilities. 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 with respect to design, regulatory and clinical requirements. Support manufacturing readiness reviews and manage design transfers to manufacturing.
Essential job functions include:
Provide 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.
Perform design and drawing reviews to ensure that components meet desired capabilities for manufacturing.
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 and resolve any inter-company conflicts effectively.
Strategically bring various cross functional teams and suppliers in alignment on outstanding issues in a timely manner.
Work with suppliers to optimize processes, reduce cost, ensure lean manufacturing as well as remove any waste from processes .
Develop and manage project milestones inline with development and commercialization needs.
Perform supplier risk & capacity assessment and take appropriate actions to ensure timely and successful commercialization
Audit suppliers for their technical capabilities as well as quality criteria.
Perform other duties and responsibilities as assigned.
Bachelor’s degree in engineering with six years of engineering experience.
Experience in the use of statistical tools required (SPC, Six Sigma, DMAIC, etc.).
On-site work required.
20% travel required.
Advanced degree is preferred.
Experience in one or more of the following: Injection Molding, Catheter manufacturing technology in the development of cardiovascular and/or endovascular devices, minimally invasive endoscopy and implantable devices.
Experience in CAPA elements and implementation.
Understanding of statistical techniques.
CAD experience using ProE/Solidworks
Strong analytical, problem solving and technical writing skills.
Strong Project management skills.
Ability to work well both independently and as a member of a team.
Effective verbal/written communication and interpersonal skills including conflict and relationship management.
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.