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Senior Engineer, R&D - Transcatheter Heart Valve

Company: Edwards Lifesciences Corp
Location: Irvine
Posted on: June 7, 2021

Job Description:

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 Senior Engineer 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, 4 years' experience in the medical device industry - OR
  • Master's Degree in Engineering, 3 years' 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

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

Keywords: Edwards Lifesciences Corp, Irvine , Senior Engineer, R&D - Transcatheter Heart Valve, Other , Irvine, California

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