Senior Engineer, NPD Manufacturing

Innovation starts from the heart. Our Advanced Innovation & Technology (AI&T) teams harness the imagination, courage, and resourcefulness to think beyond what’s currently possible, and create solutions for patients many years into the future. If you’re an early-stage innovator, then Edwards AI&T team is the place for you to take the next steps in your career. We’ll give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology.

The Senior NPD Manufacturing Engineer is responsible for providing technical ownership to successfully develop, qualify and transfer manufacturing technologies to commercialize new products in the Advanced Innovation Technology (AI & T) Business Unit. This individual will also advance the objectives of the Global Supply Chain (GSC) by supporting supply chain development and associated engineering activities from early product development through product launch while ensuring that manufacturing processes are developed that fully meet the operational needs for commercial success. The Senior Engineer will work collaboratively with R&D, supplier development, quality, Pilot ops etc., to support product development and deliver on the goals and objectives of the AI&T BU.

How you'll make an impact:

In this role, you will provide technical leadership for the design and development of manufacturing fixtures, tooling, workstations, and custom equipment that enable new product development, commercialization, and production-capacity expansion. This role is centered on hands-on engineering design and equipment development rather than day-to-day line or build management. A major focus will be identifying process bottlenecks and developing new or upgraded equipment that increases throughput, reduces cycle time and manual touch time, improves uptime, and enables scalable manufacturing capacity.

The engineer will translate product, process, user, quality, safety, ergonomic, cycle-time, and capacity requirements into robust mechanical designs, from concepts and 3D CAD models through detailed design, fabrication, assembly, debugging, testing, qualification, installation, and production release. They will work closely with R&D, Quality, Pilot Operations, Supplier Development, Sourcing, Facilities, EH&S, machine shops, equipment integrators, and other Global Supply Chain partners to deliver safe, reliable, maintainable, and compliant manufacturing solutions.

• Lead the 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 support 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 the development lifecycle.
• Perform hands-on troubleshooting and design iteration to resolve mechanical, equipment, process, reliability, usability, and manufacturability issues.
• Partner with internal machine shops, external fabricators, equipment integrators, and suppliers to support 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.

What you’ll need (Required):

• Bachelor's Degree in Engineering or Scientific field with 4 years experience including either industry or industry/education (or)
• Master's Degree or equivalent in Engineering or Scientific field with 3 years experience including either industry or industry/education (or)
• Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education 

 
What else we look for (Preferred):

• Proven expertise using the MS Office Suite, including MS Project; CAD experience preferred (if applicable).
• Strong documentation, communication (written and verbal), and interpersonal relationship skills, including consultative and relationship‑management capabilities.
• Basic understanding of statistical techniques.
• Previous experience working with lab or industrial equipment (if applicable).
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering.
• Strong problem‑solving, organizational, analytical, and critical‑thinking skills.
• Substantial understanding of processes and equipment used in assigned work.
• Good leadership skills and the ability to influence change.
• Knowledge of and adherence to Edwards Environmental Health & Safety and Quality guidelines as they relate 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.
• Ability to manage competing priorities in a fast‑paced environment.
• Ability to work effectively in a team environment, including inter‑departmental teams, and serve as a key contact representing the organization on contracts or projects.
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
• Adherence to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and taking adequate control measures to prevent injuries and environmental harm within one’s span of influence/control.

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California (CA), the base pay range for this position is $108,000 to $153,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.