Senior Supplier Development Engineer

Edwards Lifesciences; Irvine (CA); On-site; USD 106,000 - 149,000; Full time

Job summary

An established industry player is seeking a Senior Supplier Development Engineer to join their innovative team in Irvine, CA. This role involves providing engineering support for the design and development of implantable devices to treat cardiovascular diseases. You'll work closely with suppliers, lead validation activities, and ensure manufacturing readiness. The ideal candidate will possess strong analytical and project management skills, along with a background in engineering. Join a forward-thinking company dedicated to improving patient outcomes and making a significant impact in the healthcare sector.

Benefits

Competitive salaries

Performance-based incentives

Variety of benefits programs

Qualifications

• Bachelor's in Engineering with 4 years experience or Master's with 3 years.
• Experience in catheter manufacturing and statistical tools is preferred.

Responsibilities

• Provide technical input for sourcing projects and supplier capability evaluation.
• Conduct design reviews to ensure components meet manufacturing capabilities.
• Audit suppliers for technical capabilities and quality criteria.

Skills

Analytical Skills

Problem Solving

Technical Writing

Project Management

Communication Skills

Education

Bachelor's Degree in Engineering or Scientific field

Master's Degree in Engineering or Scientific field

Tools

ProE/Solidworks

Statistical Process Control (SPC)

Six Sigma

DMAIC

Job description

Please note this is an "onsite" role, and the successful candidate will be expected to work from our corporate Irvine, CA campus.

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Senior Supplier Development Engineer position is a unique career opportunity that could be your next step towards an exciting future.

The Senior Supplier Development Engineer role 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, supply chain readiness review and manage design transfers to manufacturing.

How you’ll make an impact:

• 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 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.

What you’ll need (Required Qualifications):

• Bachelor's Degree or equivalent in Engineering or Scientific field with, 4 years’ experience including either industry or industry/education OR
• Master's Degree or equivalent in Engineering or Scientific field with, 3 years’ experience including either industry or industry/education.
• On-site work required.
• Up to 20% domestic/international travel required.

What else we look for (Preferred Qualifications):

• 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.
• 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.

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.