Senior Engineer, NPI Manufacturing

Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.

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.

This Senior Engineer will provide support for new product introduction (NPI) activities for class III, implantable devices for Edwards' comprehensive portfolio of transcatheter heart valve replacement therapy. The Senior Engineer will advance the objectives of the Global Supply Chain Network by supporting supply chain development and associated engineering activities from early product development through product launch. This role is accountable for successful commercialization of new products.

How you will make an impact:

• Supporting operational transitions through development, clinical, and commercialization including completion of design transfer deliverables to ensure end-to-end readiness.
• Working cross functionally with pilot, sustaining operations, domestic and international manufacturing locations to harmonize transfer plans and validation strategies across all sites. Driving line and capacity expansion plans in manufacturing locations in collaboration with demand planning and commercial groups for uninterrupted product supply.
• Driving and leading critical integration meetings to inform stakeholders across GSC and related functions on progress and risks. Ensuring risks are clearly identified and addressed for smooth execution of development activities.
• Driving the development of supply chain strategies to attain operational efficiency including assessment of capital and operational expenses to support development needs of the products.
• Ensuring development and implementation of robust characterization and validation activities in collaboration with partners from R&D and quality, including deployment of critical control points in manufacturing.
• Identifying manufacturing and sale-up risks at pilot and production sites, and developing, implementing appropriate mitigation plans, including business continuity plans at suppliers. Ensuring clear alignment across sites to harmonize actions and site-to-site transfer of knowledge, process and practices as applicable.
• Identifying and driving continuous improvements in manufacturing processes including opportunities to incorporate digital strategy, automation initiatives, mistake proofing while elevating quality standards.
• Ensuring accuracy of part/drawings, bill of materials (BOM) and other manufacturing documentation. Leading the execution of playbooks to ensure successful assessment and deployment of sourcing, planning, transfer and supplier assessment by PDP phases.
• Working with cross functional partners to ensure design for manufacturability (DFM), Six Sigma, and LEAN considerations are incorporated into product and process designs, including design and process 3P across sites. Supporting MES deployment as needed.
• Providing analysis and tracking progress against agreed upon targets and deliverables to attain operational metrics required for successful commercialization of products.

What you’ll need (Required):

• A Bachelor's degree in Engineering or Scientific field with 4 years of previously related industry experience OR Master’s degree in Engineering or Scientific field with 3 years of previously related industry experience Required.
• Ability to travel 20% domestically or internationally, if required.

What else we look for (Preferred):

• Proven track record in design transfers to Operations and process and equipment validation
• Understanding of injection molding, polymers, medical textiles and commonly used materials in the medical device space, such as Nitinol and implantable, with working knowledge of metals processing
• Experience in developing process requirement specifications, collaborating with external parties, su