Senior Engineer, Supplier Development

Edwards Lifesciences

2d•Onsite

About The Position

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. In addition, patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. The Senior Engineer is a technical role supporting supplier excellence by deployment of technical supplier assessments, improvement plan development and execution for both TAVR and TMTT. This role is essential in mitigating risks, fostering partnerships, and promoting the growth of key strategic suppliers. The engineer will oversee technical projects related to Advanced Catheters, Extrusions, Machining, and Metal components at the supplier level. Responsibilities also include refining and advancing processes as design for manufacturability, process optimization and production release at suppliers. Project management is a critical aspect of this position, encompassing formal project planning and monitoring. This role is integral to a cross-functional team tasked with supporting sourcing strategies, which includes supplier recommendations and initiatives for business continuity.

Requirements

Bachelor's Degree or equivalent in Engineering or Scientific with 4 years of engineering experience in supplier development, process development, process validation, and/or NPD.
Experience in a highly regulated industry.
On-site work required.

Nice To Haves

Advanced degree.
Experience in the use of statistical tools required (SPC, Six Sigma, DMAIC, etc.).
Experience in catheter manufacturing technology in the development of cardiovascular and/or endovascular devices, minimally invasive endoscopy and implantable devices.
Strong analytical, problem solving and technical writing 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.

Responsibilities

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 conflict 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 in line with commercialization needs.
Perform supplier risk & capacity assessment and take appropriate actions to ensure timely and successful commercialization
Lead and support execution of Supplier Technical Assessments. Generate assessment reports and presentations.
Generate, analyze Supplier Performance Data & Metrics. Translate data into Supplier Dashboards and actionable items for driving improvements.
Develop test plans to investigate yield issues, non-conformances. Support quality improvement projects at suppliers.
Actively participate in supplier meetings and internal core team meetings while providing relevant feedback for teammates and suppliers.
Up to 25% domestic/international travel.
Perform other duties and responsibilities as assigned.