Senior Engineer, NPD Manufacturing

Edwards Lifesciences•Irvine, CA

17h

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 supports Global Supply Chain development and engineering activities from early product development through product launch, ensuring manufacturing processes meet operational needs for commercial success. The engineer works collaboratively with R&D, Supplier Development, Quality, Pilot Operations, and other partners. The position provides technical leadership for hands-on design and development of manufacturing fixtures, tooling, workstations, test systems, and custom equipment. It focuses on identifying process bottlenecks and developing new or upgraded equipment to improve throughput, cycle time, manual touch time, uptime, and scalable manufacturing capacity—not day-to-day line or build management. The engineer translates product, process, user, quality, safety, ergonomic, cycle-time, and capacity requirements into mechanical designs, taking concepts and CAD models through fabrication, assembly, debugging, testing, qualification, installation, and production release. The role partners with internal teams, machine shops, fabricators, equipment integrators, and suppliers to deliver safe, reliable, maintainable, and compliant manufacturing solutions. It also develops equipment documentation and ensures equipment and processes meet applicable quality-system, validation, and regulatory requirements.

Requirements

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

Nice To Haves

Proven 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 production-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 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 company 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, machine shops, equipment integrators, and Global Supply Chain partners.