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Edwards Lifesciences

Senior Quality Engineer - Transcatheter Mitral & Tricuspid Therapies

Edwards Lifesciences - Irvine, CA

Senior Quality Engineer - Transcatheter Mitral & Tricuspid Therapies','014130','!*!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. Please refer to the job description for additional details.Key Responsibilities:Investigate 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.Identify and ensure the optimization of complex Manufacturing and/or R&D 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.Develop, update, and maintain technical content of risk management filesDevelop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processesDevelop and validate test methods for in-process and final product testingAssign 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 procedure.Other incidental duties assigned by Leadership#LI-JE1','!*!Education and Experience:Bachelor's Degree or equivalent in Engineering or related field, 4 years experience related industry experience Required OrMaster's Degree or equivalent in Engineering or related field, 3 years experience related industry or industry/education experience Required OrPh.D. or equivalent in Engineering or related field, 0 years experience experience RequiredAdditional Skills:Proven expertise in usage of MS Office Suite; CAD experience preferredStrong documentation, communication and interpersonal relationship skills including negotiating and relationship management skillsWorking knowledge and understanding of statistical techniquesPrevious experience working with manufacturing/test equipment requiredSubstantial understanding and knowledge of principles, theories, and concepts relevant to EngineeringKnowledge of Process and Test Method validationStrong problem-solving, organizational, analytical and critical thinking skillsSubstantial understanding of processes and equipment used in assigned workGood leadership skills and ability to influence changeKnowledge of and adherence to Quality systemsKnowledge of Design Control Strict attention to detailAbility to interact professionally with all organizational levelsAbility to manage competing priorities in a fast paced environmentMust be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projectsAbility to interact with senior internal and external personnel on significant matters often requiring coordination between organizations','!*!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 10,000 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. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.','!*!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 10,000 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. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.','Quality','USA-USA-California - Irvine','','Senior Quality Engineer - Transcatheter Mitral & Tricuspid Therapies

25 days 6 hours ago

Edwards Lifesciences

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Location: Irvine, CA

Company Profile:
Edwards Lifesciences has its heart in the right place. Named for co-inventor of the first artificial heart valve Miles "Lowell" Edwards, the company is a spinoff from Baxter International. Edwards makes instruments for cardiovascular disease patients. The company focuses on cardiac surgery products, critical care products, and vascular products. Its products include replacement valves, valve repair equipment, hemodynamic monitoring systems, catheters, surgical clips and inserts, and artificial implantable grafts. Edwards markets through a direct sales force and through distributors, of which Baxter is one. Edwards operates worldwide.