Senior Engineer, New Product Introduction

Edwards Lifesciences; Irvine (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA, seeks a Senior Engineer, New Product Introduction to drive commercialization of Class III transcatheter heart valve products from early development through launch.

You will coordinate across R&D, Quality, Supplier Development and Operations to ensure scalable manufacturing, supplier readiness, and seamless global product delivery.

Qualifications

• 4+ years in NPI/NPD, manufacturing operations, design transfers or process/equipment validation.
• Ability to travel up to 20% (domestic and international).
• Onsite position in Irvine, CA.

Responsibilities

• Lead commercialization of Class III implantable THV products from development to launch.
• Coordinate design transfer deliverables for end-to-end readiness across R&D, Quality, Supplier Development and Operations.
• Drive line and capacity expansion plans with demand planning and commercial groups.

Skills

NPI/NPD experience

Manufacturing operations

Process validation

Education

Bachelor's degree in Mechanical/Manufacturing/Industrial Engineering

Job description

Imagine how your ideas and expertise can change a patient's life. Our Global Operations & Quality (GO&Q) team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You'll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.

We're dedicated to pioneering next-generation innovations for patients with aortic regurgitation (AR). Our Transcatheter Heart Valve (THV) business unit brings together Clinical Affairs, Engineering, and Research professionals to design and develop minimally invasive therapies that impact patient outcomes and quality of life. We're working together to transform cardiovascular care and device development to address unmet patient needs in structural heart disease. Join us and be part of our inspiring journey.

The Senior Engineer, New Product Introduction leads the commercialization of Class III implantable THV products, driving supply chain and manufacturing readiness from early development through product launch. This role partners across R&D, Quality, Supplier Development, and Operations to ensure scalable manufacturing processes, supplier preparedness, and seamless global product delivery, supporting successful product launches across the global supply chain network.

How you'll make an impact:

• Support operational transitions through development, clinical, and commercialization including completion of design transfer deliverables to ensure end-to-end readiness
• Partners functionally with pilot, sustaining operations and, domestic and international manufacturing locations to harmonize transfer plans and validation strategies across all sites. Drive line and capacity expansion plans in manufacturing locations in collaboration with demand planning and commercial groups for uninterrupted product supply.
• Lead critical integration meetings to inform stakeholders across GO&Q and related functions on progress and risks. Ensure risks are clearly identified and addressed for smooth execution of development activities
• Guide the development of supply chain strategies to attain operational efficiency including assessment of capital and operational expenses to support development needs of the products
• Ensure 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
• Identify manufacturing and sale-up risks at pilot and production sites, and develop, implement appropriate mitigation plans, including business continuity plans at suppliers. Ensure clear alignment across sites to harmonize actions and site-to-site transfer of knowledge, process and practices as applicable.
• Drive continuous improvements in manufacturing processes including opportunities to incorporate digital strategy, automation initiatives, mistake proofing while elevating quality standards
• Ensures accuracy of part/drawings, bill of materials (BOM) and other manufacturing documentation. Leads the execution of playbooks to ensure successful assessment and deployment of sourcing, planning, transfer and supplier assessment by PDP phases.
• Ensure design for manufacturability (DFM), Six Sigma, and LEAN considerations are incorporated into product and process designs, including design and process 3P across sites. Support MES deployment as needed
• Provide analysis and tracks progress against agreed upon targets and deliverables to attain operational metrics required for successful commercialization of products.

What you'll need (Required):

• Bachelor's degree in Mechanical, Manufacturing, Industrial Engineering, or a related technical field.
• A minimum of 4 years of experience in NPI/NPD, manufacturing operations, design transfers, and/or process/equipment validation.
• Ability to travel up to 20%, including domestic and international travel.
• Onsite position.

What else we look for (Preferred):

• Understand injection molding, polymers, medical textiles and commonly used materials in the medical device space, such as Nitinol and implantables, with working knowledge of metals processing.
• Experience in developing process requirement specifications, collaborating with external parties, suppliers and working with Operations personnel to establish efficient solution systems
• Expertise in the area of manufacturing engineering: design for manufacturability, design and process excellence methodologies including Six Sigma, LEAN experience, cGMP, EH&S guidelines, supplier development engineering and process validation.
• Excellent communication and interpersonal skills at all levels of employe