Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Engineer II, Manufacturing position is a unique career opportunity that could be your next step towards an exciting future.

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.

As a Manufacturing Engineer II, you will join our Transfer Engineering team, responsible for introducing new and innovative products and processes to the commercial manufacturing environment, which strike the necessary balance between unmet patient needs and required operational excellence.

How you will make an impact:

• Optimizing manufacturing processes, including using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and/or offering significant voice-of-factory feedback to enable the re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical engineering skills.
• Developing moderately complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyzing results, making recommendations, and developing reports.
• Analyzing and resolving moderately complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, validation finds, and audit observations).
• Developing training and documentation materials (e.g., work instructions and engineering best practices) for commercial production partners to enable the seamless knowledge transfer of project and manufacturing processes.
• Establishing project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
• Overseeing manufacturing support tasks; giving instruction to technicians on conducting tests; training technicians and providing feedback; and coordinating technician work.

What you’ll need (Required):

• A Bachelor's degree in Engineering or Scientific field with 2 years of previously related industry experience OR Master’s degree in Engineering or Scientific field Required.

What else we look for (Preferred):

• Good computer skills in usage of MS Office Suite including MS Project
• Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
• Basic understanding of statistical techniques
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Solid problem-solving, organizational, analytical and critical thinking skills
• Solid understanding of processes and equipment used in assigned work
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Knowledge of applicable FDA regulations for 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
• Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
• Ability to build productive internal/external working relationships