• Clinical Validation Engineer

    Job Locations US-WA-Bothell
    Posted Date 3 weeks ago(10/22/2018 6:58 PM)
    Requisition ID
    Company (Portal Searching)
    FUJIFILM SonoSite
  • Overview

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    Clinical Validation Engineer - Bothell, WA


    FUJIFILM, SonoSite, Inc . We are an innovative and high performance culture with tremendous opportunities.  People who work here are given the unique opportunity to contribute to the advancement of healthcare throughout the world.  Headquartered in Bothell, WA USA, FUJIFILM SonoSite is represented by a global distribution network in over 100 countries.  Since its inception, FUJIFILM SonoSite’s lightweight, robust products have created and led the point-of-care ultrasound market. From sophisticated urban hospital emergency rooms to clinics in austere, remote villages, FUJIFILM SonoSite systems are used by over 21 medical specialties and provide clinicians around the world with a cost-effective tool for improving patient safety and workflow efficiency. FUJIFILM SonoSite holds a number of prestigious design awards and has in excess of 145 patents.


    External US

    Job Summary:


    The Clinical Validation Engineer is expected to initiate, run, and support software and product Integration testing and Validation efforts through development and product cycle. The Clinical Validation Engineer will work closely with Ultrasound Engineering, Systems Engineering, Software, usability, and clinical to participate in validating design outputs, with opportunities for supporting design inputs.


    The Clinical Validation Engineer may assist in providing clinical support to product development teams in areas of product definition, product assessment, and product development.   


    Essential Job Functions:



    •  Define, document, and execute Validation tests including maintaining traceability to requirements.
    • Responsible for creating, maintaining, and distributing reports promptly and timely to support product development timelines.
    • Participate in system life cycle and software integration testing.
    • Work with  clinical specialists, software, integration team and systems engineering to  take part in validating design outputs.
    • Participate in reviews and improvement  of requirements, design documents, and overall  process.
    • Responsible for creating and having input to specific documentation, i.e.,  Product Requirements Definition, Validation Plan and Validation Report.
    • Accountable for carrying out the requirements of Fujifilm Sonosite's quality procedures.
    • Provide clinical support and input cross-functionally to the design and development process as needed.


    Knowledge and Experience:


    • Minimum of 3 years of R&D experience or equivalent.
    • Bachelor degree in Biomedical or Ultrasound preferred.  
    • Minimum of 5 years of experience utilizing Ultrasound Medical Imaging and Medical Technologies in diverse clinical environments with a firm understanding of product attributes that lead to a positive User and Patient outcomes.  ARDMS certified required.


    Skills and Abilities:


    • Must have at least (5) five years’ experience in diagnostic ultrasound, current (RDCS and/or RDMS) required.  Special attention will be paid to applicants with multiple registries.
    • Excellent organization and time management skills.
    • Self-motivated and self-starter with ability to work with minimal supervision.
    • Ability to understand both the clinical and business needs of the customer and FUJIFILM SonoSite respectively.
    • Ability to translate customer needs into clear product requirements for R&D is a must.
    • Ability to think about the application of diagnostic ultrasound in non-traditional ways is also a must.
    • Proficient with MS office.
    • Ability to lift 50 lbs.
    • Ability to work effectively in a team environment.


    FUJIFILM SonoSite, Incoffers a fantastic compensation package, including benefits, and a 401k program.  Visit us today to learn more about our exciting technologies and how you can make a difference.  To apply and obtain further details regarding key responsibilities and experience requirements, check out our careers page at   www.SonoSite.com/careers.

    FUJIFILM SonoSite, Inc.   is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age, protected veteran status, disability status, or any other characteristic protected by law. 

    In compliance with the ADA Amendments Act, should you have a disability that requires assistance and / or reasonable accommodation with the job application process, please contact the Human Resources department via phone at 425-951-1200, or via e-mail at ffss-hr@fujifilm.com .   Additionally, the affirmative program/plan is available for review upon formal request by employees and applicants for employment in the Human Resources office during regular office hours.


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