Edwards Lifesciences

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, NPD position is a unique career opportunity that could be your next step towards an exciting future.

Aortic regurgitation (AR), also known as aortic insufficiency (AI), impacts millions of people globally, yet remains underdiagnosed, undertreated and has limited options for therapy today. Edwards’ pioneering work in transcatheter aortic heart valve replacement (TAVR) is expanding to offer new treatment options for these patients living with AR throughout the globe. Our Transcatheter Heart Valve (THV) business unit partners with cardiologists and clinical teams for the goal of transforming AR 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.

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 re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design 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, audit observations).
• Developing training and documentation materials (e.g., work instructions) for production 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):

• Solid problem-solving, project management, organizational, analytical and critical thinking skills
• Strict attention to detail
• Build management experience
• 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
• Previous experience working with lab/industrial equipment
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
• 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
• 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

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, the base pay range for this position is $85,000 to $120,000 (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.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.