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.Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.This is an exciting opportunity within our Irvine Implant Manufacturing Plant supporting quality engineering for tissue and solutions used to build Surgical, THV and TMTT heart valves. The Quality Engineer will be a key member of a cross-functional core team accountable for all aspects of the Tissue & Solutions operations value stream (safety, quality, delivery, compliance) by supporting tasks for sustaining and continuous improvement initiatives. In this role, the engineer will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards’ systems’ procedures to optimize engineering activities from new product introduction, continuous improvement, global process transfers, line sustaining, validation activities and Manufacturing Execution System (MES) in our Implant Manufacturing group.Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.Key Responsibilities: Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. Optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk Identify opportunities for re-design/design of basic equipment, tools, fixtures, MES, etc. to improve manufacturing processes, and reduce risk. Develop, update, and maintain technical content of risk management files. Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes. Collaborates with R&D, NPD, Pilot, Manufacturing, Operations, and personnel at other Edwards Manufacturing facilities to support Tissue & Solutions Operations projects and activities. Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work. Train, coach, and guide lower-level employees on routine procedures, root cause analysis, and quality system compliance. Perform other duties and responsibilities as assigned.Education and Experience:Bachelor's Degree or equivalent in in Engineering or related field, 2 years related industry experience Required orMaster's Degree or equivalent in in Engineering or related field, 1 year related industry or industry/education experience RequiredAdditional Skills: Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills Proven expertise in usage of MS Office Suite Medical device industry experience is preferred Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills Strong understanding of applicable FDA regulations and ISO 13485 for medical device industry. Working knowledge and understanding of statistical techniques Previous experience working with lab/industrial equipment required 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 and adherence to Quality systems 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 Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/controlAligning 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 $83,000 to $117,000 (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 RequirementEdwards 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.
