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    R&D Engineer - Raleigh, United States - Merz North America

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    Description

    Position is responsible for collection, tabulation, and analysis of tissue and acoustic lab testing data as related to current and future devices. Part of demonstrating Ultherapy is safe and effective is determining that acoustic energy is being focused to the exact intended location, and nowhere else. As a result, Ultherapy transducers must be characterized electrically and acoustically, and precise measurements of the 3-D emitted pressure field are necessary. In addition, early assessments into the efficacy of these devices via tissue experiments are needed. The purpose of the R&D Engineer is to perform these experiments and analyses, as well as develop and implement new protocols and analyses with future prototypes. The engineer would also support and maintain the entire MDIC tissue and acoustics laboratories.
    This position will work closely with members of the Merz/Ulthera Advanced Development team as well as supporting functional groups such as new product introduction, quality and operations for current and future Merz/Ulthera products and platforms.

    Responsibilities

    • Therapy & Imaging Performance assessment:
      • Develop and acquire benchtop metrics for therapy and imaging system performance
    • Pre-clinical Laboratory Science:
      • Creating, expanding or implementing advanced histological techniques and experimental setups to match the technical needs of Ultherapy-based projects & experiments.
    • Data acquisition and analysis:
      • Collect, tabulate, and analyze data, as well as communicate experimental setup and results to technical staff and cross-functional groups through presentations or reports.
      • Support product development, preclinical and clinical trials through device verification, testing and qualification
    • Early Pipeline:
      • Support assessment of new technology for system integration
    • Laboratory methods documentation:
      • Write and revise laboratory equipment specifications, work instructions and SOPs; develop test procedures necessary for new devices. When necessary, release documents in QMS
    • Laboratory organization:
      • Maintain and organize laboratory equipment and inventory. Complete calibration when required. Work with management to specify annual capital and operating budget for lab
    • Good laboratory practice proficiency:
      • Complete knowledge in operating critical lab equipment such as oscilloscope, microscope, acoustic tank, force balance, translation stage, impedance analyzer, pulse-echo fixture, cryostats, and training others. Experience testing PCBA and soldering parts
    • Further Tasks:
      • Equipment care and maintenance
    Technical & Functional Skills
    • Exposure to programming languages (e.g. Python, MATLAB, LabVIEW, C++, CAD)
    • Proficient with Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Visio)
    • Experience with soldering, making cables, rapid prototyping, and fixture development
    Minimum Qualifications
    • Bachelor's degree in engineering, physics, or biological sciences
    • Experience with electronic instrumentation (e.g. oscilloscope, function generator, arbitrary wave form generator, translation stages, amplifiers, and rf transmitters)
    • 3+ years' experience and familiarity with equipment calibration, equipment management, and lab maintenance
    Preferred Qualifications
    • Histologic Technician training at a certified training program/healthcare careers college or equivalent experience meeting the high complexity requirement.
    • 3+ years' experience in setting up and performing routine pathology techniques including H&E and special stains.
    • Experience with technical report writing and executing test protocols, work instructions and SOPs
    • Experience in a regulated industry with ISO13485, 21 CFR medical devices, and quality management systems
    Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

    The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR c)

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