Sr. Engineer, Supplier Development Engineering

Edwards Lifesciences • Irvine, CA

1d • $106,000 - $149,000 • Onsite

About The Position

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 Principal Engineer, Supplier Development position is a unique career opportunity that could be your next step towards an exciting future. You’ll make an impact by: The Sr. Engineer, R&D Supplier Development will reside in the Transcatheter Mitral and Tricuspid Therapies (TMTT) 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 the 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 (IQ, OQ, PQ), 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. 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 development and 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.

Requirements

• 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

Nice To Haves

• Experience in the use of statistical tools (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.

Responsibilities

• Conduct engineering activities from the 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 (IQ, OQ, PQ), 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.
• 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 development and 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees