Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

　　* This role requires domestic travel up to 20% to visit suppliers and our Irvine site *

　　How you will make an impact:

　　Investigate moderately complex manufacturing product quality and compliance issues (including evaluation of source materials and suppliers) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.

　　Optimizing moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identifying opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.

　　Developing, updating, and maintaining technical content of risk management files.

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

　　Assigning support tasks; giving instruction to technicians on conducting tests; training technicians and providing feedback; and may coordinate technician work.

　　What you’ll need (Required):

　　Bachelor's Degree in Engineering or related field with 2 years of previously related industry experience OR Master’s Degree in Engineering or related fieldWhat else we look for (Preferred):

　　Experience with equipment, process, and tooling fixture validations

　　Experience with test method validations

　　Experience supporting a line transfer

　　Experience with design control and FMEA

　　Experience writing protocols and reports

　　Experience interacting with suppliers

　　Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills

　　Basic understanding of statistical techniques

　　Previous experience working with lab/industrial equipment

　　Solid problem-solving, organizational, analytical and critical thinking skills

　　Knowledge of and adherence to Quality systems

　　Strict attention to detail

　　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

　　Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

　　COVID Vaccination Requirement

　　Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

　　Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.

　　For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.