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

Innovation starts from the heart. Our Advanced Technology (AT) 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 AT 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.

How you will make an impact:

• Providing manufacturing engineering support in the design and development of delivery systems and accessories used to treat cardiovascular disease. Conducting engineering activities from early product development through product launch.

• Developing manufacturing capability to meet requirements including procurement, development, and qualification of manufacturing equipment. Developing manufacturing processes and procedures (JDOC and MES). Conducting studies to characterize new manufacturing processes. Developing and executing process validation plans.

• Conducting design/process reviews and applying DFM concepts and principles to ensure DFM considerations are incorporated into designs. Deploying Lean concepts and principles into line and work station designs.

• Identifying and ensuring implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc. are up to standards.

• Developing complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyzing results, making recommendations, and developing reports.

• Developing training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.

What you’ll need (Required):

• A Bachelor's degree in Engineering or Scientific field with 4 years of previously related industry experience OR Master’s degree in Engineering or Scientific field with 3 years of previously related industry experience Required.

What else we look for (Preferred):

• Experience with thermal bonding such as (RF, Split Die, Radial Compression, Lasers) preferred

• Previous component and fixture design experience preferred

• Proven expertise in usage of MS Office Suite including MS Project; CAD experience

• Strong 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 preferred

• 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 ability to influence change

• 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 inter-departmental teams and key contact representing the organization on contracts or projects

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 $106,000 to $149,000 (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.