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Engineer II, R&D Transcatheter Heart Valve

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: April 5, 2021

Job Description:

We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. USA - California - Irvine We have an exceptional opportunity for an experienced medical device engineer with technical leadership to contribute to the cutting edge Transcatheter Heart Valve program. This individual will be a technical contributor responsible for providing engineering support to the design and development of medical devices or components in support of company's strategic plan. The Engineer II applies knowledge of technical principles and Edwards systems/procedures to optimize product development. Additional duties include, but not limited to:

Key Responsibilities: Support Heart Valve Testing operations as a member of an advanced development team Apply biomedical and mechanical engineering knowledge to the testing and evaluation of new products for the Transcatheter Heart Valve market Solve mechanical engineering problems at the component through system level Develop test methods and gather and analyze hydrodynamic performance and durability data for implantable devices Create, test, and/or improve products by developing complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles Interface with R&D, manufacturing, clinical affairs, quality, and regulatory personnel to ensure compliance with internal and external policies and procedures, QSR, and FDA regulations Assign R&D support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work Train, coach, and guide lower level employees on routine procedures Required Qualifications: Bachelor's Degree in Engineering, 2+ years' experience in the medical device industry - OR - Master's Degree in Engineering, 1+ year experience in the medical device industry Experience to include medical device product development, writing test protocols and writing reports Strong documentation skills; strong technical writing ability and good verbal communication skills Proven expertise in usage of MS Office Suite; CAD experience Hands on experience with laboratory practices including setting up and conducting lab tests Demonstrated effectiveness in working within a team environment Experience with hydrodynamic, durability and fatigue testing Understanding of Mitral anatomy Preferred Qualifications: Prefer experience with Nitinol Prefer experience with Heart Valve Testing Basic understanding of statistical techniques Strong problem-solving, organizational, analytical, and critical thinking skills Good leadership skills and ability to influence change Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast-paced environment E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Full time Req-7491 About Us 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.

Keywords: Edwards Lifesciences Gruppe, Irvine , Engineer II, R&D Transcatheter Heart Valve, Engineering , Irvine, California

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