Senior Engineer, New Product Introduction

Edwards Lifesciences • Irvine, CA

1d • $108,000 - $153,000 • Onsite

About The Position

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

The position supports operational transitions through development, clinical, and commercialization phases, including design transfer deliverables. It partners with pilot, sustaining operations, and domestic and international manufacturing locations to coordinate transfer plans, validation strategies, and capacity expansion. The role also guides supply chain strategy, validation and characterization activities, risk mitigation, continuous improvement, manufacturing documentation, and progress tracking against commercialization targets.

Requirements

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

Nice To Haves

• Understanding of injection molding, polymers, medical textiles, and materials commonly used in medical devices, such as Nitinol and implantables, with working knowledge of metals processing.
• Experience developing process requirement specifications, collaborating with external parties and suppliers, and working with Operations personnel to establish efficient solution systems.
• Expertise in manufacturing engineering, including design for manufacturability and design and process excellence methodologies.
• Six Sigma and LEAN experience, and knowledge of cGMP, EH&S guidelines, supplier development engineering, and process validation.
• Excellent communication and interpersonal skills across employee levels, including upper management, suppliers, operators, and external parties.
• Excellent problem-solving, organizational, analytical, and critical-thinking skills, including discretion and judgment in decision-making.

Responsibilities

• Support operational transitions through development, clinical, and commercialization, including completing design transfer deliverables to ensure end-to-end readiness.
• Partner with pilot and sustaining operations and domestic and international manufacturing locations to harmonize transfer plans and validation strategies across sites.
• Drive manufacturing line and capacity expansion plans with demand planning and commercial groups to support uninterrupted product supply.
• Lead integration meetings to inform GO&Q and related-function stakeholders about progress and risks, ensuring risks are identified and addressed.
• Guide supply chain strategies that improve operational efficiency, including assessment of capital and operating expenses for product development needs.
• Develop and implement robust characterization and validation activities with R&D and Quality partners, including deployment of critical manufacturing control points.
• Identify manufacturing and scale-up risks at pilot and production sites and develop and implement mitigation plans, including supplier business continuity plans.
• Align sites on actions and harmonize knowledge, processes, and practices for site-to-site transfers as applicable.
• Drive continuous improvements in manufacturing processes, including digital strategy, automation, mistake-proofing, and elevated quality standards.
• Ensure accuracy of parts, drawings, bills of materials (BOMs), and other manufacturing documentation.
• Lead execution of playbooks for sourcing, planning, transfer, and supplier assessment by product development phase.
• Incorporate design for manufacturability (DFM), Six Sigma, and LEAN considerations into product and process designs, including design and process 3P across sites.
• Support Manufacturing Execution System (MES) deployment as needed.
• Analyze and track progress against agreed targets and deliverables to achieve operational metrics required for successful product commercialization.

Benefits

• Competitive salaries
• Performance-based incentives
• A wide variety of benefits programs to address the diverse individual needs of employees and their families

What This Job Offers

• Job Type: Full-time
• Career Level: Senior