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.

You’ll make an impact by:

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.

What you’ll need:

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.

What else we look for:

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.

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California (CA), the base pay range for this position is $106,000 to $149,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.   

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.