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Engineer II (R&D)

Orange County Metro Area, CA

Posted: 09/11/2019 Job Type: Engineering Job Number: JN -092019-25587

Engineer II (R&D)

Lifesciences Industry

Irvine, CA


This is an exciting opportunity for an Engineer II within the Transcatheter Heart Valve (THV) R&D Valve Testing Group. As part of this team, you will be responsible for supporting R&D activities for THV R&D Valve Testing, legacy product modifications and THV R&D Valve Testing laboratory operations.

Job Functions / Responsibilities

  • Support a range of laboratory engineering activities with focus on THV R&D Valve Testing and legacy product modification including feasibility evaluations, product design verification, test method validation, and equipment validation (e.g. standard and custom test equipment).
  • Design, develop, and qualify LabVIEW based software, test fixturing / tooling, test equipment and/or test methods to be used in device qualification testing including writing and executing protocols, statistical data analysis and authoring reports.
  • Partner with THV R&D engineers for device development including: rapidly prototyping designs, evaluating materials, troubleshooting failures, proposing and evaluating design improvements.
  • Identify opportunities for design / re-design of software, test equipment, tools, fixtures, etc. to improve existing test methods and lab processes.
  • Develop and execute feasibility studies, software modification, equipment qualification, test method, software validation and / or product verification protocols / reports and technical reports. May also be responsible for developing test methods and test strategy.
  • May create, update and optimize laboratory test methods and standard operating procedures.
  • Employ use of statistical analysis techniques and statistical experimental design, as appropriate.

Qualifications

Required Skills, Experience and Education:

  • Engineer II level position requires a Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or Electrical Engineering or related engineering discipline. Master's Degree or equivalent in Engineering preferred.
  • 2+ years experience in medical device or similar regulated industry. Experience in medical device development, software development for LabVIEW cRio system, software and/or equipment validation and test method validation is strongly preferred.

Skills/Experience To Include The Following

  • Working knowledge in developing and maintaining LabVIEW cRIO systems with large number of sensors, such as pressure, flow, thermal and high-speed imaging instrumentation.
  • Knowledge of Simple State Machine Architecture, Queues and Notifiers communication methods, XML formatting
  • Previous exposure to Automated Test System, LabVIEW RealTime, MATLAB, and Linux OS is highly desirable.
  • Proficiency in advanced 3D CAD modelling (Solidworks) using curves and surfaces is required.
  • Strong prototyping skills are highly valuable.
  • Ability to work well both independently and as a member of a cross-functional team in a dynamic environment is essential.
  • Solid problem-solving, organizational, analytical and critical thinking skills.
  • Excellent teamwork and interpersonal skills including negotiating and relationship management.
  • Must be able to effectively articulate, verbally and in writing, results and conclusions to technical and non-technical personnel. Must have strong technical writing skills.
  • Solid understanding and knowledge of engineering principles, theories, and concepts.
  • Capability to quickly learn and interpret complex test systems is required.
  • Must be a highly motivated self-starter who is driven to achieve quality and value-add results with appropriate direction. Candidate must seek direction when appropriate.
  • Ability to build productive internal/external working relationships.
  • Clear understanding of good documentation practices and medical device quality system regulations and requirements.
  • Working knowledge and understanding of statistical techniques required.
  • Proficiency in Microsoft Office Suite and Minitab required.
  • Previous experience in medical device testing and/or process development preferred. Prior work experience in a lab environment with flow, pressure, leak, tensile, thermal and other test instrumentation is desirable.


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