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Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. 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:

+ 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 ensuring 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.

+ Analyzing and resolving 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.

+ Leading and 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.

+ Collaborating across sites and cross functional teams (R&D and commercial).

+ Coordinating manufacturing builds and raw material allocations.

+ Leading process validations (IQ, OQ, PQ).

+ Supporting documentation for the team.

What you’ll need:

+ Bachelor's degree in Engineering or Scientific field with 6 years of engineering experience.

+ Medical device or regulated industry experience.

What else we look for:

+ Technical team leadership capability with strong self-motivation, project management skills, and demonstrated ability to lead a cross functional team while optimizing resources to deliver project results.

+ Demonstrated experience of Phase-Gate Product Development Process.

+ Understands FDA regulations for medical device industry.

+ Strong understanding of Design for Manufacturing (DFM) principles.

+ Ability to work on complex problems and projects where analysis of situation or data requires an in-depth, solid understanding of engineering principles.

+ Effective verbal/written communication and interpersonal skills including conflict and relationship management.

+ Proven expertise in usage of MS Office Suite including MS Project.

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 $118,000 to $167,000 (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.