Principal Engineer, Supplier Development Engineering

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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 toward an exciting future.

• The Principal Engineer, Supplier Development 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 the initial product development phase through product launch.
• Provide technical input for strategic sourcing projects, including evaluation of supplier capability, part qualification plan, specification review, product implementation and part transition to manufacturing.
• Develop manufacturing technologies to meet new product demands.
• Support manufacturing readiness reviews, supply chain readiness reviews, and manage design transfers to production environment.
• Manage product phase in/phase out activities around design, regulatory and clinical requirements.
• Lead supplier validation activities, support milestone builds and commercialization of new product introduction. Integrate new products into manufacturing.
• Conduct reviews to ensure DFM considerations are incorporated into designs. Assess and develop supplier part capability.
• 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.
• Lead recurring technical meetings with critical outsourced component/assembly suppliers.
• 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.

• Bachelor’s Degree in Engineering or Scientific field, minimum of 6 years of experience OR
• Master’s Degree in Engineering or Scientific field, minimum of 5 years of experience OR
• Ph.D. or equivalent in Engineering or Scientific field, minimum of 2 years of experience.
• On‑site work required.
• Up to 20% domestic/international travel.

• Experience in the use of statistical tools required (SPC, Six Sigma, DMAIC, etc.).
• Experience in catheter assembly and related sub‑assembly components manufacturing technologies in the development of cardiovascular and/or endovascular devices, minimally invasive endoscopy and implantable devices.
• Proven expertise in usage of MS Office Suite.
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills.
• Ability to translate technical information to all levels of the organizations.
• Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering.
• Advanced problem‑solving, organizational,…