Engineer II, New Product Development

Edwards Lifesciences • Irvine, CA

1d • Onsite

About The Position

Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our New Product Development Engineering team, you will work closely with our R&D and Quality teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around the world. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

Requirements

• Bachelor's Degree in Engineering or Scientific field with 2 years related experience including either industry or industry/education OR Master's Degree in Engineering or Scientific field or equivalent with related internship, senior projects, or thesis in industry/education

Nice To Haves

• Strong foundation in engineering principles and problem solving, with the ability to apply theory to real‑world manufacturing and product development challenges.
• Demonstrated experience working with lab or industrial equipment (as applicable), including hands‑on interaction with manufacturing processes, test setups, and tooling.
• Working knowledge of medical device regulations and quality systems, including FDA requirements and Edwards Environmental Health & Safety (EHS) and Quality standards for clean‑room manufacturing.
• Proficiency with engineering and productivity tools, including MS Office (Excel, Word, PowerPoint) and MS Project; CAD experience preferred where applicable.
• Solid understanding of manufacturing processes and equipment, with the ability to identify risks, opportunities, and improvement areas across assigned workstreams.
• Basic understanding of statistical techniques used for process characterization, capability evaluation, and data‑driven decision making.
• Strong documentation and communication skills, both written and verbal, with the ability to clearly convey technical information to diverse audiences.
• Ability to collaborate effectively across functions and externally, including working with vendors, suppliers, and project stakeholders.
• Proven ability to manage multiple priorities in a fast‑paced environment, maintaining focus, organization, and follow‑through.
• High attention to detail and commitment to quality, particularly in regulated environments where accuracy and traceability are critical.
• Professional presence and interpersonal effectiveness, with the ability to interact confidently at all organizational levels.
• Team‑oriented mindset, with the ability to build productive working relationships and contribute to shared project outcomes.
• Commitment to adhering to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and taking appropriate measures to prevent injuries, protect the environment, and reduce pollution within one’s scope of influence.

Responsibilities

• Drive manufacturing design control for new products and processes, ensuring robust, compliant maturation from early builds through commercialization.
• Translate product design into scalable, repeatable manufacturing solutions by applying manufacturing engineering principles, Edwards systems, and operational standards.
• Own and develop manufacturing documentation across the product lifecycle, including drawings, routers, SOPs, pFMEAs, work instructions, and training materials to enable seamless knowledge transfer to production.
• Partner with R&D, Quality, Pilot, and Operations to define and refine processes during QST, pre‑DV, DV, and early builds—supporting root cause investigations and design-for-manufacturability improvements prior to commercialization.
• Develop and execute process characterization, experiments, and test protocols to establish process understanding, capability, and control.
• Support and execute manufacturing qualifications and validations (IQ, OQ, Software) to ensure processes meet regulatory, quality, and business requirements.
• Influence product and process specifications from an operations perspective, including DFx, tolerancing, materials selection, and automation, while establishing stability metrics and proactively mitigating risk through SCRR, MRR, and related forums.
• Serve as the Voice of the Factory, leveraging SME product and process knowledge to identify gaps, elevate risks, and drive continuous improvement.
• Collaborate on manufacturing equipment and tooling development, including concept input, design refinement, and readiness for production use.
• Support manufacturing and compliance issue resolution, including CAPA, non‑conformances, audit observations, and process transfer activities.
• Identify and implement improvements to processes, equipment, tools, and fixtures using engineering problem‑solving approaches, LEAN principles, and basic statistical methods.
• Execute project deliverables to plan, leveraging project management tools such as schedules, risk analyses, and action tracking to meet customer and program expectations.
• Provide technical leadership on the factory floor, including guiding technicians and junior engineers, overseeing test execution, delivering training, and providing real‑time feedback.
• Perform additional responsibilities as needed to support program success and business priorities.

Benefits

• competitive salaries
• performance-based incentives
• a wide variety of benefits programs to address the diverse individual needs of our employees and their families

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees