Principal Engineer, Supplier Development

Edwards Lifesciences • Irvine, CA

1d • 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. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Principal Engineer, Supplier Development will be part of the THV Supplier Development Engineering team, providing manufacturing engineering leadership to support the design, development, and commercialization of implantable devices and catheter‑based delivery systems for the treatment of cardiovascular disease.

Requirements

• Bachelor's degree in engineering or scientific, with 6 years of experience in new product development, process development, commercialization, and/or operations engineering in a medical device industry.
• Travel up to 25% domestically and internationally.
• On-site work required.

Nice To Haves

• Master’s degree in engineering and/or MBA.
• Experience in medical device new product development, including successful design optimization and progression from early development through commercialization.
• Background in at least two of the following areas: interventional access devices, rapid product development, component-level manufacturing, or complex assembly design.
• Hands-on experience with catheter manufacturing processes, such as extrusions, braiding, molding, laser welding, and bonding techniques.
• Demonstrated capability to apply sound engineering judgment and technical expertise to solve complex problems; working knowledge of DFM, GD&T, and Six Sigma methodologies.
• Proven ability to manage and collaborate with external vendors to meet quality, timeline, and technical requirements.
• Strong experience in rapid product development within cross‑functional teams, including creative design iteration, prototyping, and test method development (e.g., in‑vitro testing).

Responsibilities

• Provide technical leadership for strategic sourcing initiatives, including supplier capability assessments, part qualification strategies, specification reviews, and transition of products into manufacturing.
• Develop and mature manufacturing technologies and processes to support new product requirements and scale‑up needs.
• Support manufacturing readiness reviews (MRR) and supply chain readiness reviews (SCR), and lead robust design transfer activities into the production environment.
• Manage product phase‑in and phase‑out activities, ensuring alignment with design, regulatory, clinical, and manufacturing requirements.
• Lead supplier validation activities and support milestone builds, NPI commercialization, and seamless integration of new products into manufacturing operations.
• Drive Design for Manufacturability (DFM) by conducting design, drawing, and specification reviews to ensure components meet manufacturing capability and quality expectations.
• Assess, develop, and continuously improve supplier part and process capability through data‑driven evaluations and technical collaboration.
• Actively engage suppliers in technical discussions to identify and implement product and process improvements that enhance quality, reliability, and cost effectiveness.
• Define and execute supplier qualification and validation requirements for OEMs, contract manufacturers (component and device level), and custom material suppliers.
• Lead recurring technical reviews and performance meetings with critical outsourced component and assembly suppliers.
• Respond with urgency to supplier‑related quality issues, driving root cause analysis, corrective actions, and clear escalation and communication as needed.
• Ensure Tier 1 suppliers effectively manage and qualify Tier 2 suppliers, resolving inter‑company issues to protect product quality and supply continuity.
• Align cross‑functional teams (R&D, Quality, Operations, Supply Chain, Regulatory) and suppliers to resolve open issues and meet program timelines.
• Partner with suppliers to optimize manufacturing processes, reduce cost, support lean manufacturing initiatives, and eliminate waste.
• Develop and manage project plans and milestones to support development, validation, and commercialization objectives.
• Perform supplier risk, capacity, and continuity assessments, and drive mitigation plans to ensure successful on time commercialization.
• Audit supplier technical capabilities and quality systems to ensure compliance with performance, regulatory, and quality requirements.

Benefits

• competitive salaries
• performance-based incentives
• 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: Principal
• Number of Employees: 5,001-10,000 employees