Senior Engineer, NPD Manufacturing

Edwards Lifesciences • Irvine, CA

2d • $108,000 - $153,000

About The Position

The Senior NPD Manufacturing Engineer provides technical ownership for developing, qualifying, and transferring manufacturing technologies to commercialize new products in the Advanced Innovation & Technology (AI&T) Business Unit. The role also supports Global Supply Chain development and engineering from early product development through product launch, ensuring manufacturing processes meet operational needs for commercial success. The engineer collaborates with R&D, Supplier Development, Quality, Pilot Operations, and other partners to deliver AI&T product-development objectives.

The role provides hands-on technical leadership in mechanical design and equipment development, including manufacturing fixtures, tooling, workstations, test systems, and custom equipment. It focuses on addressing bottlenecks and developing or upgrading equipment to increase throughput, reduce cycle and manual touch time, improve uptime, and scale manufacturing capacity—not on day-to-day line or build management.

The engineer translates product, process, user, quality, safety, ergonomic, cycle-time, and capacity requirements into mechanical designs, and supports the full lifecycle from concept and CAD through fabrication, assembly, debugging, testing, qualification, installation, and production release. The role partners with internal and external teams to deliver safe, reliable, maintainable, and compliant manufacturing solutions.

Requirements

• Bachelor's degree in Engineering or a scientific field and 4 years of experience, including industry or industry/education experience; or
• Master's degree or equivalent in Engineering or a scientific field and 3 years of experience, including industry or industry/education experience; or
• Ph.D. or equivalent in Engineering or a scientific field, with industry or industry/education experience.
• Strong documentation, written and verbal communication, and interpersonal relationship skills, including consultative and relationship-management capabilities.
• Basic understanding of statistical techniques.
• Substantial understanding of engineering principles, theories, and concepts, and of processes and equipment used in assigned work.
• Strong problem-solving, organizational, analytical, and critical-thinking skills.
• Good leadership skills and ability to influence change.
• Knowledge of and adherence to Edwards Environmental Health & Safety and Quality guidelines relevant to clean-room medical-device manufacturing.
• Knowledge of applicable FDA regulations for the medical-device industry.
• Strict attention to detail and ability to interact professionally with all organizational levels.
• Ability to manage competing priorities in a fast-paced environment and work effectively on interdepartmental teams.
• Ability to serve as a key organizational contact on contracts or projects and interact with senior internal and external personnel on significant matters requiring coordination between organizations.
• Adherence to company rules and requirements, including pandemic protocols and EH&S rules, and use of adequate control measures to prevent injuries and environmental harm within one's span of influence or control.

Nice To Haves

• Expertise using the MS Office Suite, including MS Project.
• CAD experience, if applicable.
• Previous experience working with laboratory or industrial equipment, if applicable.

Responsibilities

• Lead end-to-end mechanical design and development of manufacturing fixtures, tooling, workstations, test systems, and custom equipment for new products, process scale-up, and capacity expansion.
• Develop new equipment and upgrade existing equipment to eliminate bottlenecks, improve uptime and overall equipment effectiveness, expand output, and meet forecasted capacity needs without compromising quality or compliance.
• Develop and compare fixture and equipment concepts using engineering analysis, prototyping, proof-of-concept testing, and risk assessment.
• Evaluate manual, semi-automated, and automated equipment alternatives and recommend solutions based on capacity gain, technical feasibility, quality risk, reliability, maintainability, floor-space impact, cost, and implementation complexity.
• Create and maintain 3D CAD models, detailed drawings, assemblies, bills of materials, design specifications, tolerance analyses and stack-ups, and GD&T documentation for medium- to high-complexity mechanical designs.
• Apply design-for-manufacturing-and-assembly, reliability, maintainability, ergonomics, and EH&S principles throughout development.
• Troubleshoot and iterate designs hands-on to resolve mechanical, equipment, process, reliability, usability, and manufacturability issues.
• Partner with internal machine shops, external fabricators, equipment integrators, and suppliers on design refinement, component selection, fabrication, assembly, debugging, and commissioning.
• Lead fixture and equipment characterization, verification, qualification, and validation, including test plans, protocols, acceptance criteria, traceability, and reports.
• Create and maintain equipment documentation, including specifications, spare-parts recommendations, preventive-maintenance requirements, calibration needs, troubleshooting guidance, and training materials.
• Apply technical principles and Edwards systems and procedures to optimize manufacturing processes and ensure fixtures, equipment, and documentation comply with applicable quality-system, validation, and regulatory requirements.
• Collaborate with R&D, Quality, Pilot Operations, Supplier Development, Sourcing, Facilities, EH&S, and Global Supply Chain partners to support product development and 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